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临床试验/CTRI/2024/04/066053
CTRI/2024/04/066053尚未招募不适用

IMPACT OF PROTOCOLIZED DE-RESUSCITATION WITH FRUSEMIDE/RENAL REPLACEMENT THERAPY COMPARED WITH STANDARD INTERVENTION IN CRITICALLY ILL PATIENTS ON MORTALITY IN A TERTIARY CARE HOSPITAL

AMRITA SHAH1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2024年5月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
198
试验地点
1
主要终点
Mortality at 28 days

研究概览

简要总结

Fluid administration in ICU has been divided 4 phases: Resuscitation, Optimisation, Stabilisation, and Evacuation (ROSE), followed by risk of Hypoperfusion. Intravenous fluid is administered during initial phase of resuscitation to counter dehydration, as diluents to give medications and in cases of shock.1 In certain cases, this can result in a positive fluid balance. During stabilization phase, we target for late Conservative Fluid Management (LCFM) and during evacuation phase goal directed fluid removal is advocated. Malbrain et al (2014) defined late Conservative Fluid Management (LCFM) as two consecutive days of negative fluid balance within the first week of ICU stay.Late Goal Directed Fluid Removal (LGFR) – defined as more aggressive and active fluid removal by means of diuretics and renal replacement therapy with net ultrafiltration.1

A positive cumulative fluid balance in critically ill patients have been associated with poor clinical outcomes including poly-compartment syndrome, increased mortality and intra-abdominal hypertension.1 In septic patients, a positive fluid balance was found to be a strongest predictors of death.2 The fluid overload state can result in affecting the cardiovascular system (causing myocardial oedema, conduction disturbance, impaired contractility, diastolic dysfunction, myocardial depression, pericardial effusion), central nervous system(cerebral oedema, impaired cognition, delirium , increased intracranial pressure, cerebral perfusion pressure  and intra-ocular pressure), respiratory system( causing pulmonary oedema, pleural effusion, altered pulmonary and chest wall elastance, impaired gas exchange and increased work of breathing), gastrointestinal system(impaired synthetic function, cholestasis, Impaired cytochrome P 450 activity, hepatic compartment syndrome), renal system(renal interstitial oedema, increased renal blood flow, increased renal vascular resistance ,salt retention , water retention and renal compartment syndrome), gastro-intestinal system(ascites formation, gut oedema ,malabsorption ,ileus , increased Abdominal perfusion pressure, increased  Bowel contractility , increased IAP and APP and abdominal compartment syndrome).1 A positive fluid balance is independently associated with impaired organ function and an increased risk of death.2,3

Following hemodynamic stabilization, it is important to understand whether liberal or conservative fluid management and strategic removal of excess fluid impacts ICU outcomes. The reason we have taken up this study is -even though most studies have mentioned a positive fluid balance is harmful after optimal stabilization1,2,3, studies on how much, methods of removal and to what extent the removal of excess fluids can help in such outcomes are varied and with variable results. We have designed a protocol for the same to assess its impact on clinical outcomes.

  1. Malbrain, Manu & Marik, Paul & Witters, Ine & Cordemans, Colin & Kirkpatrick, Andrew & Roberts, Derek & Regenmortel, Niels. Fluid overload, de-resuscitation, and outcomes in critically ill or injured patients: A systematic review with suggestions for clinical practice. Anaesthesiology intensive therapy.Nov 2014;46(5):361-80
  2. Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53.
  3. Murphy CV, Schramm GE, Doherty JA et al.: The importance of fluid management in acute lung injury secondary to septic shock. Chest 2009; 136: 102�’109.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • At least 2 days of ICU admission Older than 18 years.

排除标准

  • 1.Patient’s refusal.
  • 2.Patient younger than 18 years.
  • 3.Length of ICU stay < 2 days 4.Lactates>4 5.Norepinephrine/epinephrine> 0.2 mcg/kg/min/>1 vasopressor in use 6.Patients with subarachnoid haemorrhage.

结局指标

主要结局

Mortality at 28 days

时间窗: 28 DAYS

次要结局

  • Hospital and ICU mortality(Mechanical ventilator free days)

研究者

发起方
AMRITA SHAH
申办方类型
Private hospital/clinic

研究点 (1)

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