| 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
|
|
|
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
|
|
|
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. |