| 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
|
|
|
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
|
|
|
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 |