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CTRI Number  CTRI/2024/08/072561 [Registered on: 16/08/2024] Trial Registered Prospectively
Last Modified On: 22/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Surgical/Anesthesia
Diagnostic 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison of two types of intravenous fluid therapy in bowel obstruction surgery 
Scientific Title of Study   Comparison of effect of plasmalyte and ringer lactate on acid base status and lactate in patients undergoing emergency gastrointestinal obstruction surgery- A pragmatic randomised control 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  Nithiyashree S 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Institute of Post Graduate Medical Education and Research 
Address  Department of Anaesthesiology and Critical care , Old Block , Second floor, Jawaharlal Nehru Institute of Post Graduate Medical Education and Research , Dhanvanthri nagar , Puducherry-605006
Department of Anaesthesiology and Critical Care , Old block, Second floor, Jawaharlal Nehru Institute of Medical Education and Research , Dhanvanthri nagar , Gorimedu - Puducherry-605006
Pondicherry
PONDICHERRY
605006
India 
Phone  7639292555  
Fax    
Email  jr8241@jipmer.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Ajay Kumar Jha 
Designation  Additional Professor 
Affiliation  JIPMER, Puducherry 
Address  Department of ANESTHESIOLOGY, Jawaharlal Nehru Institute of Medical Education and Reseach ,Dhanvantary Nagar
Dhanvantary Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  09868477642  
Fax    
Email  drajaykjha@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Ajay Kumar Jha 
Designation  Additional Professor 
Affiliation  JIPMER, Puducherry 
Address  Department of ANESTHESIOLOGY, Jawaharlal Nehru Institute of Medical Education and Research ,Dhanvantary Nagar
Dhanvantary Nagar
Pondicherry
PONDICHERRY
605006
India 
Phone  09868477642  
Fax    
Email  drajaykjha@rediffmail.com  
 
Source of Monetary or Material Support  
Intra Mural Fund , Jawaharlal Nehru Institute of Medical Education and Research, Puducherry -605006 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NOT APPLICABLE] 
 
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 SNithiyashree  Jawaharlal Nehru Institute of Medical Education and Research  Department of Anesthesiologyand Criticalcare ,old block, second floor , JIPMER , Dhanvanthri nagar , Puducherry-605006
Pondicherry
PONDICHERRY 
07639292555

jr8241@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIESCDSCO Reg. No. ECR/342/Inst/PY/2013/RR-19  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, (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Plamalyte  Plamalyte arm receives plasmalyte as only fluid throughout surgery.  
Comparator Agent  Ringer lactate infusion  Infusion will be administered throughout the surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA 1,2,3 physical status.
Patients undergoing emergency gastro intestinal obstruction surgery. 
 
ExclusionCriteria 
Details  Mechanical ventilation
Inotropes
Acute or chronic kidney disease 
 
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 ringer lactate on post operative PH, Strong ion difference and lactate in patients undergoing emergency gastro intestinal obstruction surgery   1 hour after surgery, 24 hour after surgery, at the time discharge 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect on acute kidney injury marker (kidney injury molecule -1 )
To compare the effect of predefined composite of renal, cardiovascular and respiratory system complications 
At the end of study .(2 years approx) 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   27/08/2024 
Date of Study Completion (India) 15/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Written informed consent explaining about the procedure, risks and any adverse events will be obtained from the patients before being enrolled into the study. The patient will be enrolled in 1:1 ratio. Relevant demographic data and investigation details will be obtained from the case sheet.

Anesthetic management:

Before anesthetic induction, standard ASA monitoring including pulse oximetry (SpO2), non-invasive blood pressure, 5 lead echocardiography (ECG) will be attached to patients. A wide bore iv cannula will be inserted. However, the attending anesthesia team will be allowed to use central venous catheter and/or arterial catheter if required according to their discretion. Regional anesthesia technique, choice and dosage of local anesthetic agent will be decided by the attending anesthesia team. Anesthesia induction will begin with preoxygenation for a minimum of 3 minutes followed by rapid sequence induction. Anesthesia induction will be achieved by inj. Fentanyl (2 mcg/kg), thiopentone (4-5 mg/kg) and succinylcholine (0.5-1 mg/kg).

Patients will be randomized into two arms. In one arm, patients will receive plasmalyte (Baxter India Pvt Ltd, Haryana, India) infusion throughout the intraoperative period. In the 2nd arm, patients will receive ringer lactate infusion throughout the intraoperative period. The amount of fluids will be decided by the attending anesthesia team according the hemodynamic parameters of the patients.    Blood loos will be replaced by crystalloid (ringer lactate or plasmalyte depending upon the arm the patients assigned to, colloids and packed cells in 1:3; 1:1 and 1:1 ratio. Pain management, and regional anesthesia management will be decided by the attending anesthesiologist. The mean blood pressure will be maintained preferably between 65-100 mm Hg. Hypotension and hypertension will be managed using mephenteramine/noradrenaline bolus or infusion and nitroglycerine/beta-blockers. However, the attending anesthesiologist will have freedom to choose or add inoconstrictor, inodilator, vasodilators of their own choice to manage hypotension or hypertension. Nonetheless, if the attending anesthesiologist prefer to manage hypotension by intravenous infusion, they will be allowed either plasmalyte or ringer lactate according the arm patients assigned to. Colloids and blood component infusion will be decided entirely by the attending anesthesia team.    Maintenance of anesthesia will be done using Isoflurane (1-2%) in FiO2 (40% with air) and supplemental fentanyl boluses (0.5 mcg/kg). Ventilator settings will be adjusted to maintain ETCO2 (end tidal carbon dioxide) between 35-45 mm Hg. Hemoglobin will be maintained > 8 gm/dl and PRBC will be transfused accordingly. Blood sugar will be maintained between 100-200 mg/dl. Hypothermia will be prevented to maintain core body temperature between 35-37 C.

Lactate, acid-base status, electrolytes and KIM-1 level were assessed just before study fluid administration and 1-2 hours after completion of surgery. Patients were monitored everday to asses the cardiovascular, pulmonary and renal complications till date of discharge from the hospital

 
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