1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response (Others) -  By request to the study PI


6. For how long will this data be available start date provided 01-08-2024 and end date provided 31-07-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


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

Background:

Endogenous gasotransmitters are small gaseous transmitters generated in the human body. It is postulated that dysregulation in the gasotransmitter system contributes to the pathophysiology of several disorders. (1,2) Critical illness often results from a cascade of exaggerated pro-inflammatory and anti-inflammatory responses, (3,4) some of which may be mediated by endogenous gasotransmitters. The relevance and profile of these gasotransmitters in the context of critical illness has however not been studied.

Study objectives:

1.      To describe the profile of gasotransmitters hydrogen sulphide (H2S), hydrogen peroxide (H202) and nitric oxide (NO) among a cohort of critically ill adult patients admitted to a tertiary care hospital in India.

2.      To describe the profile of these gasotransmitters in distinct diagnostic groups such as Acute Respiratory Distress Syndrome (ARDS), Sepsis, Trauma and Brain injury (traumatic and non-traumatic).

3.      To identify gasotransmitter thresholds at admission (within first 24hrs) that are predictive of poor outcomes for critically ill patients.

Study population:

Inclusion criteria:

-        All adult patients admitted to the ICU and anticipated to stay for at least 24hrs

-        Patients should be receiving organ support in the form of oxygen therapy (any device), vasopressors (any dose) or kidney replacement therapy (other than maintenance dialysis)

-        Patients admitted from the Emergency room or transferred from the in-patient wards (within 7 days from their original day of admission to the hospital) to the ICU

Exclusion criteria:

-        Patients anticipated to survive <24hrs at the time of ICU admission

-        Patients admitted to an outside hospital for >48hrs prior to admission to our hospital

Variables:

The key exposures will be the levels of gasotransmitters at the time of admission and the key outcome will be ICU mortality. Secondary outcomes will include hospital mortality, length of stay and receipt of organ support during ICU stay.

Study procedures:

We will collect blood samples for the measurement of all three gasotransmitters every 8h for the first 24hrs and then once a day for the first 5 days of ICU admission or until discharge or death (whichever is earlier). 1-3ml of blood is required for each analysis and efforts will be made to synchronize these blood draws with the timing of any other blood tests in order to minimize discomfort to the patients.

Our group has developed bedside microfluid probes for the detection of these gasotransmitters and we will be employing these devices for our measurements.