E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fluid overload associated with acute kidney injury in patients admitted to the intensive care unit |
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E.1.1.1 | Medical condition in easily understood language |
Fluid overload associated with acute kidney injury in patients admitted to the intensive care unit |
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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 | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069339 |
E.1.2 | Term | Acute kidney injury |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10016803 |
E.1.2 | Term | Fluid overload |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022519 |
E.1.2 | Term | Intensive care |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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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 |
The objective of this pilot trial is to assess the feasibility of forced fluid removal in high-risk AKI patients with severe fluid overload. The intervention will use furosemide infusion and/or CRRT to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the KDIGO guidelines. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age ≥ 18 years of age • Acute Kidney Injury defined according to the KDIGO criteria • Renal Recovery Score ≤ 50%. (Calculated using www.renal-recovery-score.com) • Fluid overload defined as a positive fluid balance ≥ 10% of admission body weight. • Able to undergo randomization within 12 hours of fulfilling other inclusion criteria
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E.4 | Principal exclusion criteria |
• Known allergy to furosemide or sulphonamides • Known pre-hospitalization advanced chronic kidney disease (GFR < 30 mL/minute/1.73 m2 or chronic RRT). • Severe hypoxic respiratory failure (use of invasive ventilation and FiO2 > 80% and PEEP > 10 cm H2O) • Severe burn injury (≥ 10% TBSA) • Severe dysnatremia (< 120 or > 155 mmol/l) • Hepatic coma • Mentally disabled undergoing forced treatment • Pregnancy/breast feeding • Lack of commitment for on-going life support including RRT • Lack of informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative fluid balance 5 days after randomisation. o Calculated as the sum of daily intake – daily output, as registered on the daily ICU observation charts.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
5 days after randomization |
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E.5.2 | Secondary end point(s) |
• Mean daily fluid balance during ICU stay • Cumulative fluid balance during the entire ICU stay. • Number of patients with one or more major protocol violations. • Time to neutral cumulative fluid balance • Accumulated SAR’s in each intervention arm during the ICU stay.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
90 days after randomization |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard of care, with no restrictions in the use of the IMP |
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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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The trial will end at day 90 after the randomization of the last patient. This is to ensure 90 days of followup for all patients |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |