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    Summary
    EudraCT Number:2007-005547-17
    Sponsor's Protocol Code Number:RHMNUT0048
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2010-06-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2007-005547-17
    A.3Full title of the trial
    Refeeding risks in patients requiring nutrition support. A twin centre double-blind randomised controlled trial of parenteral nutrition support.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Refeeding risks in patients requiring nutrition support
    A.3.2Name or abbreviated title of the trial where available
    Refeeding risks in patients requiring nutrition support
    A.4.1Sponsor's protocol code numberRHMNUT0048
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN74013349
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSouthampton University Hospital NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute of Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIntravenous nutrition regimen A (Lower energy)
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSynthamin 14 electrolyte-free
    D.3.9.1CAS number 8100001047
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.22
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClinoleic 20%
    D.3.9.1CAS number 8100001149
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.61
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucose 10%
    D.3.9.1CAS number 8000011167
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38.44
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucose 5%
    D.3.9.1CAS number 8000011167
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28.83
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium glycerophosphate 21.6%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.67
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride 30%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.34
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride 15%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.54
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium sulphate 50%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium chloride 14.7%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.31
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCernevit (1 vial in 10ml)
    D.3.9.1CAS number 8100001014
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.77
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSelenase 0.64 micromoles selenium per ml
    D.3.9.1CAS number 10102188
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZinc sulphate 1mmol in 10ml
    D.3.9.1CAS number 7733020
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.08
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeParenteral nutrition regimen comprising existing and recognised parenteral nutrition components, most have a Marketing Authorisation but if not are manufactured under a MHRA UK Manufacturing licence
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIntravenous nutrition regimen B (Higher energy)
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSynthamin 14 electrolyte-free
    D.3.9.1CAS number 8100001047
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38.44
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClinoleic 20%
    D.3.9.1CAS number 8100001149
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.22
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucose 50%
    D.3.9.1CAS number 8000011167
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.22
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlucose 5%
    D.3.9.1CAS number 8000011167
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number19.22
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium glycerophosphate 21.6%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.67
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride 30%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.34
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride 15%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.54
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium sulphate 50%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCalcium chloride 14.7%
    D.3.9.1CAS number 8100001058
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.31
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCernevit (1 vial in 10ml)
    D.3.9.1CAS number 8100001014
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.77
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSelenase 0.64 micromoles selenium per ml
    D.3.9.1CAS number 10102188
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.05
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZinc sulphate 1mmol in 10ml
    D.3.9.1CAS number 7733020
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.08
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeParenteral nutrition regimen comprising existing and recognised parenteral nutrition components, most have a Marketing Authorisation but if not are manufactured under a MHRA UK Manufacturing licence
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients who have a non-functioning gastrointestinal tract require artifical intravenous nutrition. This is usally a result recent surgery or sepsis causing a reversible short term paralysis of the bowel. These patients are often very unwell with infection, electrolyte disturbances, fluid balance abnormalities or other surgical complications. What is not known is what level of feeding provision is needed in the short term.
    E.1.1.1Medical condition in easily understood language
    To determine the right level of feeding into a vein to give to patients who are unable to eat.
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We aim to clarify whether the cautious approach to feeding (advocated by the NICE guidelines) is important by conducting a prospective randomised double blind controlled trial looking for the early changes of refeeding problems in patients who would be considered to be at risk on NICE defined criteria when commencing their nutrition support at levels recommended by NICE (approx 50% of their estimated needs) or at levels considered acceptable in other guidelines (approx 100% of their estimated needs).

    Therefore, the principal research objective is to determine the occurrence of Refeeding risk characterised by a fall below the lower limit of normal (LLN) or a significant decrease in concentration, within 1 week of randomisation, in any one of potassium, magnesium or phosphate levels or a rise in blood sugar (in non-diabetic patients) to levels requiring insulin infusion (above 11mmol/l or standard hospital practice) in patients fed at 100% compared with those fed at 50% of their est
    E.2.2Secondary objectives of the trial
    Our secondary objectives are to determine whether there are any clinical or economic consequences to developing refeeding syndrome. Specifically we are aiming to compare the incidence of the following parameters in the group fed at 100% with those fed at 50% of estimated requirements.

    • Need in any one of Mg, PO4, K or insulin infusion within 1 week of randomisation

    • Fluid overload manifestations of refeeding syndrome as assessed by clinical oedema score (day 3) and bioimpedance assessments of body water, water distribution and phase angle

    • Refeeding related intracellular electrolyte disturbance and arrthymia risk as reflected in abnormal QT interval on ECG

    • Rates of infection in first week of feeding which may be increased by hyperglycaemia or fluid overload

    • Length of Stay

    We will also conduct an analysis of both strategies of feeding (100% vs 50%) to determine the overall cost of the lower vs. higher feeding approaches in malnourished patients.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All consenting adults or those for whom consent can be gained from a close family member/friend or professional legal representative (minimum 18 years old) who require intravenous nutrition as assessed by the Southampton University Hospitals NHS Trust and the Royal Berkshire NHS Foundation Trust Nutrition Support Teams.
    2. Who do not require specialised parenteral nutrition regimens to meet their clinical needs.
    3. Who are at moderate or high risk of refeeding problems as defined by:

    Moderate risk: 1 of the following criteria - BMI <18.5 kg/m2, unintentional weight loss >10% in 3-6 months or very little or no food intake for >5days.

    High risk: 1 of the following criteria - BMI <16 kg/m2, unintentional weight loss >15%, very little nutritional intake for >10 days; or 2 of the following lesser criteria - BMI <18.5 kg/m2; weight loss >10%; very little nutritional intake for >5 days.
    E.4Principal exclusion criteria
    •Patients at very high risk of re-feeding syndrome (2 or more of the NICE criteria (BMI<16, recent weight loss >15% body weight within-6 months, > 10 days with no nutritional intake) or patients with a BMI < 14))
    •If after careful clinical assessment the investigator feels that the patient is not at an unusually high risk from refeeding, they can be considered for inclusion if:
    Magnesium level no greater than 0.2mmol below lower limit of normal
    Phosphate level no greater than 0.2mmol below lower limit of normal
    Potassium level no greater than 0.5mmol below lower limit of normal
    •Patients with established oral nutritional intake
    •Patients weighing 100kg or more, after adjusting for oedema.
    E.5 End points
    E.5.1Primary end point(s)
    The occurrence of a ‘Refeeding Risk is characterised by
    a. a fall below the lower limit of normal (LLN)within 1 week of commencing feeding in the serum concentration of potassium (K), magnesium (Mg) or phosphate (P04) OR a significant decrease in the serum concentration of potassium (K), magnesium (Mg) or phosphate (P04) according to the 'least significant difference' method, within 1 week of commencing feeding OR

    b. for participants who already have a K, Mg or PO4 concentrations below the lower limit of normal on day 0 - a significant decrease in the serum concentration of potassium (K), magnesium (Mg) or phosphate (P04) according to the 'least significant difference' method, within 1 week of commencing feeding OR

    c. a rise in blood sugar to levels requiring insulin infusion (above 11mmol/l or standard hospital practice)in non-diabetic patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week
    E.5.2Secondary end point(s)
    1. Requirement for supplemental administration of Mg, PO4, K or insulin infusion within 1 week of randomisation.
    2. The presence of fluid overload manifestations of refeeding syndrome as assessed by clinical oedema score (Appendix 1) and (day 3) bioimpedance assessments of body water, water distribution and phase angle (Appendix 2).
    3. Possible refeeding related intracellular electrolyte disturbance and arrythymia risk as reflected in abnormal QT interval on ECG.
    4. Rates of infection in first week of feeding which may be increased by hyperglycaemia or fluid overload.
    5. Length of Stay.
    6. We will also conduct an analysis of both strategies of feeding (100% vs 50%) to determine the overall cost of the lower vs. higher feeding approaches in malnourished patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of hosptial stay
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    Comparison of PR1 and PR2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be the completion of the final patient undergoing this trial, which will include hospital length of stay.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 115
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 115
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who may be ventilated, have septic delirium or be receiving sedating drugs as part of their standard clinical management
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state230
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 230
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The only difference between routine clinical care and the intervention is that subjects randomised to the intervention limb of the trial would receive full rate feeding for the first 48 hours (as opposed to half rate feeding in routine care). All trial subjects would continue to receive parenteral nutrition for as long as was clinically indicated so therefore the concern that subjects need continued provision of the intervention does not apply.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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