E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major abdominal surgery, by laporotomy. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065498 |
E.1.2 | Term | Infusion site anesthesia |
E.1.2 | System Organ Class | 100000004867 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
This study will examine whether there is a significant difference in postoperative outcomes between GDFT using a colloid solution versus a crystalloid solution.
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E.2.2 | Secondary objectives of the trial |
Study of the differences between the two groups for the following points: mortality, length of hospitalization, fluid balance, transfusion rate, incidence of hypotension, need of vasopressors and mean cardiac index.
Addition of a monitoring of the long term effects (at 6 months and 1 year post surgery) of both fluids (balanced cristalloids and colloids) on hepatic and renal function, occurence of pruritus and patient quality of life. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Adult patients (over the age of 18) undergoing elective major abdominal surgery that is expected to take longer than 3 hours and requiring a general anesthesia and a minimally invasive cardiac output monitoring (Vigileo/Flotrac).
• Patients who provide written informed consent
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E.4 | Principal exclusion criteria |
•Patients under 18 years of age
•Patients not undergoing surgery, requiring anesthesia, or cardiac output monitoring.
•Patients with arrhythmia and/or atrial fibrillation
•Patients who are allergic to HES
•Patients with renal insufficiency (serum creatinine of >2 mg/ml) or hepatic dysfunction (liver enzymes >1.5)
•Patients who has coagulation disorders (please define: values higher than 1.5x normal values.
•Patients without the capacity to give written informed consent or refusal of consent.
•Patients included in another protocol within a period of 3 months or Participating in another randomised trial.
•Pregnancy at time of enrolment.
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference between the 2 groups in postoperative morbidity identified with the Post-Operative Morbidity Survey (POMS score) on postoperative days 2. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Difference in 30-day post-operative mortality between the 2 groups
- Difference in duration of hospital length of stay as well as ICU length of stay.
- Fluid balance during surgery
- Transfusion rate
- Incidence of hypotension (defined as total case time spent with 20% drop from baseline preoperative blood pressure).
- Need of vasopressors
- Mean case cardiac index (L /BSA), Mean case cardiac stroke volume index (mL/ BSA).
- Hepatic and renal function: assessed in the blood samples taken according to the standard of care, closest to 6 months and 1 year after surgery.
- Prurit apparition: phone call at 6 months and 1 year after surgery.
- Patient quality of life: assessed by phone by means of the Whodas scale, 6 months and 1 year after surgery. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to one year after the surgery |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
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When 160 patients have been enrolled and fully followed according to protocol. (LVLS)
The end of trial will be defined as the last follow-up according to protocol. It will take place one year after the last patient's surgery. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |