1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response (Others) - 


6. For how long will this data be available start date provided 05-05-2024 and end date provided 11-05-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

  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 stabilization^1,2,3, 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.