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CTRI Number  CTRI/2024/02/062440 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 06/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   An observational trial to study the effect of fluid accumulation on acute confusional state in patients admitted to the intensive care unit(ICU) with severe infection using CAM-ICU score and a non-ivasive monitor called functional near-infrared spectroscopy (fNIRS) for forebrain mapping. 
Scientific Title of Study   Effect of cumulative fluid balance on delirium predicted by CAM-ICU and functional near-infrared spectroscopy (fNIRS) guided mapping of frontal cortex in critically ill patients with septic shock- a prospective observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenupriya Arasu 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India
Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India
New Delhi
DELHI
110029
India 
Phone  07708024354  
Fax    
Email  meenupriya1193@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Akhil Kant Singh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India
Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India
New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  dr.akhilsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Meenupriya Arasu 
Designation  Senior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India
Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India

DELHI
110029
India 
Phone  07708024354  
Fax    
Email  meenupriya1193@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Scineces, AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Research and Intramural Grant, AIIMS, New Delhi  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meenupriya Arasu  All India Institute of Medical Sciences (AIIMS)  Department of Anaesthesiology and Critical care, Academic section, 5th floor, AIIMS, Ansari nagar, New Delhi, India
New Delhi
DELHI 		 07708024354

meenupriya1193@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Postgraduate Research, AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL as this is an observational study 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Admitted to the ICU within 24 hours of having been diagnosed with septic shock.
Defined by Sepsis-3 consensus guidelines as a suspected or confirmed source of infection with Sequential organ failure assessment (SOFA) more than or equal to 2 and shock.
Shock is defined as hypotension requiring persistent vasopressor therapy to maintain mean arterial pressure (MAP) of more than 65 mmHg and serum lactate levels greater than 2 mmol per L despite adequate initial fluid resuscitation (at least 30ml per kg of IBW). 
 
ExclusionCriteria 
Details  Patients on short term mechanical ventilation less than 48 hours.
A pre-ICU diagnosis of cognitive dysfunction as indicated by their medical records on admission, or a primary central nervous system diagnosis like cerebrovascular accident, meningitis, seizure disorder, psychiatric disorder, hypoxic encephalopathy post cardiac arrest.
Death before assessment of ICU-delirium within 3 days of ICU admission.
Life-threatening bleeding, the presence of hemorrhagic shock, as judged by research or treating clinicians.
Burns, Pregnancy.
Referral from or treated at other healthcare facilities.
Patients with a likely extracerebral source of serum S100B elevation (e.g., severe disabling neuromuscular disorders, severe burns, advanced malignancy, polytrauma, and chronic renal failure).
Readmission to ICU.
Withdrawal of consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To analyze the correlation of day-7 cumulative fluid balance with the incidence of delirium, during the first 7 days of ICU admission.  From day 1 to day 7 after ICU admission 
 
Secondary Outcome  
Outcome  TimePoints 
To study the association of cumulative fluid balance with the changes in frontal cortex using fNIRS in patients with delirium.  on day1, 4 and 7 after ICU admission 
To assess the correlation of cumulative fluid balance with the average days of delirium (CAM-ICU positive days)
 		 From day 1 to day 7 after ICU admission 
To assess the correlation of cumulative fluid balance with the average comatose (RASS -4 and-5) days  From day 1 to day 7 after ICU admission 
To assess the correlation of cumulative fluid balance with the severity of delirium using CAM-ICU-7 Delirium Severity Scale  From day 1 to day 7 after ICU admission 
To assess the effect of other risk factors of delirium.  From day 1 to day 7 after ICU admission 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  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

  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 - Proposals should be directed to [meenupriya1193@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
    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
Brief Summary  

For patients admitted with septic shock to Intensive Care Unit of All India Institute of Medical sciences, New Delhi, the sensors of fNIRS (NIRSport) monitor will be placed on day 1,4,7 and clinical, laboratory, hemodynamic parameters including CAM-ICU score, the cumulative fluid balance will be recorded for 7 days after ICU admission. The treating physicians will be blinded to the case enrollment and the observed outcome of interest. An independent investigator apart from the treating ICU team will assess the daily fluid balance and another investigator will assess for delirium and fNIRS readings at various time points from day 1 to day 7 after ICU admission. Administration of antibiotics, source control, vasopressors, inotropic agents, glucocorticoids, insulin, IV albumin, blood products, renal replacement therapy, nutrition. Use of diuretics will be at the discretion of the treating physician and the same will be noted. Delirium bundle (ABCDEF) will be followed in all patients enrolled for the study, to curtail the effect of confounding factors. All the collected data will be tabulated in Microsoft Excelâ„¢ [Microsoft Corp., Redmond, Washington], and statistical analysis will be performed using SPSS 20.0 software (SPSS Inc, Chicago, Illinois, USA). The statistical analysis of fNIRS data (change in Oxyhemoglobin values in mmol/dl) will be done using NIRSLABv2019.4 using SPM (Statistical Parametric Mapping) and MATLAB 2022 (Mathworks Ltd.

 
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