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CTRI Number  CTRI/2024/06/068479 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Plasmalyte or normal saline: the future of IV fluids. 
Scientific Title of Study   Comparison of the effect of Plasmalyte and Normal saline on intraoperative inotropes and vasopressors requirements in patients undergoing emergency gastrointestinal perforation surgery- A pragmatic randomised controlled trial 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Niteesh 
Designation  Junior Resident, Dept of Anaesthesiology and Critical care 
Affiliation  JIPMER 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry,

Pondicherry
PONDICHERRY
605006
India 
Phone  9444859830  
Fax    
Email  niteesh1niteesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Lata Gupta 
Designation  Professor -dept of Anaesthesiology and Critical care 
Affiliation  JIPMER 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry,

Pondicherry
PONDICHERRY
605006
India 
Phone  9487315913  
Fax    
Email  jd0330@jipmer.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Suman Lata Gupta 
Designation  Professor -dept of Anaesthesiology and Critical care 
Affiliation  JIPMER 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry,

Pondicherry
PONDICHERRY
605006
India 
Phone  9487315913  
Fax    
Email  jd0330@jipmer.ac.in  
 
Source of Monetary or Material Support  
JIPMER INTRAMURAL FUND, JIPMER, GORIMEDU, DHANVANTARI NAGAR, PUDUCHERRY, 605006 
 
Primary Sponsor  
Name  Jipmer intramural grant 
Address  JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 
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 Suman Lata Gupta  Jawaharlal Institute of Postgraduate and Medical education and Research  EMERGENCY OPERATION THEATRE, DEPT OF ANAESTHESIOLOGY, JIPMER Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.
Pondicherry
PONDICHERRY 		 9488830091

jd0330@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee of JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Normal saline  It is given intravenously as maintenance and resuscitative fluid therapy in the Normal saline group. This is given from the onset of surgery till the surgery is completed. Volume of Normal saline to be given is decided by the treating anesthesiologist(usually 100ml/hr in addition to deficit and blood loss). 
Intervention  Plasmalyte  It is given intravenously as maintenance and resuscitative fluid therapy in the plasmalyte group. This is given from the onset of surgery till the surgery is completed. Volume of plasmalyte to be given is decided by the treating anesthesiologist (usually 100ml/hr in addition to deficit and blood loss). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) American Society of Anesthesiologists (ASA) physical status I, II, III and IV
2) Patient undergoing emergency gastrointestinal perforation surgery 
 
ExclusionCriteria 
Details  1) Patient already receiving mechanical ventilation
2) Patient already receiving inotrope
3) Acute or chronic preexisting kidney disease
4) Uncontrolled diabetes mellitus/patients requiring insulin therapy
5) History of known anaphylactic reaction
6) Hyperkalemia
7) patients with hepatic dysfunction (total bilirubin above 2mg/dl, sgot and sgpt values more than 2 times normal values) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine and compare the effect of plasmalyte and 0.9% saline on intraoperative vasopressors and inotropes requirements undergoing emergency gastrointestinal perforation surgery.  At the end of study. (2yrs approx) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect on postoperative acid-base status and lactate  At the end of study. (2yrs approx) 
To compare the effect on acute kidney injury marker (kidney injury molecule-1)
 		 At the end of study. (2yrs approx) 
To compare the effect of predefined composite of renal, cardiovascular and respiratory system complications
 		 At the end of study. (2yrs approx 
To compare the effect on in-hospital mortality, intensive care unit stay and hospital stay  At the end of study. (2yrs approx) 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/08/2024 
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="2"
Months="0"
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [niteesh1niteesh@gmail.com].

  6. For how long will this data be available start date provided 20-08-2027 and end date provided 20-08-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This study is a pragmatic, randomised, controlled trial, comparing the effect of  plasmalyte and 0.9% saline on intraoperative vasopressor and inotrope requirement undergoing emergency gastrointestinal perforation surgery. It will be conducted in patients coming to JIPMER, Puducherry  hospital. The primary outcome measures will be intraoperative vasopressor and inotrope requirement in these two groups. Secondary outcome will be their effect on acid base balance and lactate. Effect on acute kidney injury molecule. Comparing the effect of predefined composite of renal, cardiovascular and respiratory system complications and effect on in hospital mortality, intensive care unit stay and hospital stay. 
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