Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.

Официальное название

Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).

Обзор

This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.

Подробное описание

Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.

Вмешательства

• Препарат Furosemide
  Furosemide 10 mg/ml for injection/infusion
• Препарат Isotonic saline
  Isotonic saline used as placebo (injection/infusion)

Первичные конечные точки

• Days alive and out of hospital [Срок оценки: 90 days after randomization]

Вторичные конечные точки (7)

• All cause mortality [Срок оценки: 90 days after randomization]
• Mortality and life support [Срок оценки: 90 days after randomization]
• Mortality 1 year [Срок оценки: one year after randomization]
• Serious adverse events and reactions [Срок оценки: 90 days]
• Health related quality of life [Срок оценки: 1 year after randomization]
• Cognitive function [Срок оценки: 1 year after randomization]
• Health related quality of life [Срок оценки: 1 year after randomization]

Критерии участия

Inclusion Criteria: ALL below must be met.

• Acute admission to the intensive care unit.
• Age ≥ 18 years of age
• Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance.
• Clinical stable (minimum criteria: MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L)

Критерии исключения

• Known allergy to furosemide or sulphonamides.
• Known pre-hospitalization advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m\^2 or chronic RRT).
• Ongoing renal replacement therapy.
• Anuria > 6 hours.
• Rhabdomyolysis with indication for forced diuresis
• Ongoing life-threatening bleeding as these patients need specific fluid/blood product strategies.
• Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy.
• Severe dysnatremia (p-Na < 120 or > 155 mmol/L) as these patients need a specific fluid strategy.
• Severe hepatic failure as per the clinical team.
• Patients undergoing forced treatment.
• Fertile women (women < 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG.
• Consent not obtainable as per the model approved for the specific trial site.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Дания · 16 центров

• Department of Intensive Care, Sygehus Sønderjylland Aabenraa — Aabenraa
• Departmen of Intensive Care — Aalborg
• Department of Intensive Care, Aarhus University Hospital — Aarhus
• Department of Intensive Care, Rigshospitalet — Copenhagen
• Departement of Intensive Care, Gentofte Hospital — Gentofte Municipality
• Department of Intensive Care, Herlev Hospital — Herlev
• Department of Intensive Care, Regionshospital Gødstrup — Herning
• Department of Intensive Care, Nordsjællands hospital — Hillerød
• … и ещё 8 центров

Чехия · 3 центра

• Department of Intensive Care, University Hospital of Ostrava — Ostrava
• Department of Intensive Care, University Hospital of Pilsen — Pilsen
• Department of Intensive Care, IKEM — Prague

Австралия · 2 центра

• Department of Intensive Care, Liverpool Hospital — Sydney
• Department of Intensive Care, Royal North Shore Hospital — Sydney

Финляндия · 2 центра

• Department of Intensive Care, Tampere University Hospital — Tampere
• Department of Intensive Care — Turku

Норвегия · 2 центра

• Department of Intensive Care, Ålesund Sjukehus — Ålesund
• Department of Intensive Care, Stavanger University Hospital — Stavanger

Iceland · 1 центр

• Department of Intensive Care, Landspitali National University Hospital of Iceland — Reykjavik

Литва · 1 центр

• Vilnius University Hospital Santaros Clinics — Vilnius

Нидерланды · 1 центр

• Department of Critical Care, University Medical Center Groningen — Groningen

Швейцария · 1 центр

• Department of Intensive Care, Inselspital — Bern

Публикации

• Wichmann S, Lange T, Perner A, Gluud C, Itenov TS, Berthelsen RE, Nebrich L, Wiis J, Brochner AC, Nielsen LG, Behzadi MT, Damgaard K, Andreasen AS, Strand K, Jarvisalo M, Strom T, Eschen CT, Vang ML, Hildebrandt T, Andersen FH, Sigurdsson MI, Thomar KM, Thygesen SK, Troelsen TT, Uusalo P, Jalkanen V, Illum D, Solling C, Keus F, Pfortmueller CA, Wahlin RR, Ostermann M, Aneman A, Bestle MH. Furosemi PMID 37691474
• Wichmann S, Itenov TS, Berthelsen RE, Lange T, Perner A, Gluud C, Lawson-Smith P, Nebrich L, Wiis J, Brochner AC, Hildebrandt T, Behzadi MT, Strand K, Andersen FH, Strom T, Jarvisalo M, Damgaard KAJ, Vang ML, Wahlin RR, Sigurdsson MI, Thormar KM, Ostermann M, Keus F, Bestle MH. Goal directed fluid removal with furosemide versus placebo in intensive care patients with fluid overload: A trial protoc PMID 35898170

Идентификаторы

NCT: NCT04180397 · GODIF · 2024-512186-14-00 · 2019-004292-40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗