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CTRI Number  CTRI/2025/03/083243 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 22/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of two different type of intravenous fluid on electrolyte level in blunt trauma abdomen patients  
Scientific Title of Study   Comparative study of two balanced salt solutions on electrolyte balance and acid base status in patients undergoing emergency exploratory laparotomy for blunt abdomen trauma under general anaesthesia A prospective randomised double blind 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  Rubapriya J 
Designation  Junior Resident, Anaesthesiology 
Affiliation  Institute Of Medical Sciences, BHU 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony,

Varanasi
UTTAR PRADESH
221005
India 
Phone  7373066820  
Fax    
Email  rubapriya1407@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr yashpal Singh 
Designation  Professor 
Affiliation  Institute Of Medical Sciences, BHU 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony,

Varanasi
UTTAR PRADESH
221005
India 
Phone  9918424416  
Fax    
Email  dryashtrauma@bhu.ac.in  
 
Details of Contact Person
Public Query
 
Name  Dr yashpal Singh 
Designation  Professor 
Affiliation  Institute Of Medical Sciences, BHU 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony,

Varanasi
UTTAR PRADESH
221005
India 
Phone  9918424416  
Fax    
Email  dryashtrauma@bhu.ac.in  
 
Source of Monetary or Material Support  
Trauma centre, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Banaras Hindu University 
Address  Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Varanasi-221005, Uttar Pradesh, India.  
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 Rubapriya J  Trauma Centre, Institute of medical science  Department of Anaesthesiology, Banaras Hindu University, Varanasi-221005.
Varanasi
UTTAR PRADESH 
07373066820

rubapriya1407@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Of Medical Sciences ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S369||Injury of unspecified intra-abdominal organ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Balanced crystalloid-Acetated solution  Infusion of Balanced crystalloid- Acetated solution(sterofundin) from the start of surgery to the end of surgery 
Comparator Agent  Balanced Crystalloid-Lactated Ringer Solution  Infusion of Balanced Crystalloid-Lactated Solution(Ringer lactate) from the start of surgery to the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients undergoing exploratory laparotomy for blunt abdomen trauma
2.Duration of surgery for more than one hour.

 
 
ExclusionCriteria 
Details  1.Refusal to participate in the study.
2.Patients with electrolyte and pH variability.
3.Patients with end organ damage.
4.Patients on inotropic support before the start of surgery.
5.Pregnancy.
6.Patients having Patient INR more than 2.0
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of acid base balance and electrolyte status  Baseline and at 30 min (after surgery)  
 
Secondary Outcome  
Outcome  TimePoints 
pH level   Baseline & at 30 min after surgery 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   09/04/2025 
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="0"
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 - NO
Brief Summary  

Fluid therapy plays a important role in the management of patients undergoing major surgery for trauma. Most of the fluid given perioperative are comprises of maintenance fluid, replacement of on-going losses and correction of hypovolemia. Therefore, the hydrating solution should ideally have a composition of electrolytes as similar to plasma. Surprisingly, no such fluid is available. Controversy still exists regarding use of various type of fluids intraoperatively. Crystalloid is the most commonly used intraoperative fluid due to less expensive, readily available, compatible with other medicines and reaction free. Although data on clinical outcomes associated with crystalloid infusion are heterogeneous,whereas advantages of balanced salt solutions might include a lower need of blood products, lower incidence of renal replacement therapy, hyperkalemia and postoperative infections. Taken together, a critical appraisal of the data suggests that balanced salt solutions  deserve consideration as infusates of first choice. Ringer Lactate (RL) solution is the most commonly used balanced salt solution intraoperatively since long time, However Ringer Lactate is slightly hypotonic due to lower sodium level (Na=130mmol/l) than plasma (Na= 140 mmol/l) and also having lactate which has been associated with hyperlactemia, calcium interface with coagulation profile of patients if used extensively. But Sterofundin have sodium of 140mmol/L which is isotonic to plasma and seems to remain intravascular more in comparison to fluid containing serum sodium of 130mmol/L(RL), subsequently causing less hemodynamic instability.

              Recent critical care review has brought lactated solution into question with its hepatic mediated metabolism and increased aerobic demand making it not a good choice for patient with liver injury. Unlike lactated solution, acetated solution has acetate which is more rapidly metabolised extrahepatically and with less oxygen demand and can reduce liver metabolic burden for patients with damaged liver. In blunt abdomen trauma cases electrolyte imbalance and acid base changes already exist in majority of patients. To prevent further de-arrangement type of fluid using in the intraoperative period as maintanence plays an important role. So we plan this study to compare lactated solution with acetated solution on electrolyte balance and acid-base status in blunt abdomen trauma cases undergoing emergency laparotomy under general anaesthesia.


 
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