| CTRI Number |
CTRI/2020/10/028716 [Registered on: 29/10/2020] Trial Registered Prospectively |
| Last Modified On: |
17/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the effect of two balanced crystalloid intraoperative (iv) solutions ( plasmalyte vs sterofundin) on lactate levels during major cancer surgeries. |
|
Scientific Title of Study
|
Comparison of the effect of intraoperative fluids (plasmalyte vs sterofundin) during major oncological surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
deepti gupta |
| Designation |
Attending consultant, anaesthesia |
| Affiliation |
Rajiv Gandhi cancer institute and research centre Rohini sector 5 |
| Address |
C102, venus apartment, opposite sainik vihar gate no. 4, Pitampura, Delhi-110034
Department of anaesthesia, Rajiv Gandhi cancer institute and research centre
Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi 110085
North West
DELHI
110034
India |
| Phone |
7065840893 |
| Fax |
|
| Email |
mamcdeepti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
deepti gupta |
| Designation |
Attending consultant, anaesthesia |
| Affiliation |
Rajiv Gandhi cancer institute and research centre Rohini |
| Address |
C102, venus apartment, opposite sainik vihar gate no. 4, Pitampura, Delhi-110034
Department of anaesthesia, Rajiv Gandhi cancer institute and research centre
Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi 110085
New Delhi
DELHI
110034
India |
| Phone |
7065840893 |
| Fax |
|
| Email |
mamcdeepti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
deepti gupta |
| Designation |
Attending consultant, anaesthesia |
| Affiliation |
Rajiv Gandhi cancer institute and research centre Rohini |
| Address |
C102, venus apartment, opposite sainik vihar gate no. 4, Pitampura, Delhi-110034
Department of anaesthesia Rajiv Gandhi cancer institute and research centre
Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi 110085
New Delhi
DELHI
110034
India |
| Phone |
7065840893 |
| Fax |
|
| Email |
mamcdeepti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi cancer institute and research centre Rohini |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi cancer institute |
| Address |
Rajiv Gandhi cancer institute and research centre
Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi 110085 |
| 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 |
| Deepti |
Rajiv Gandhi cancer institute and research centre Rohini |
Operation theatre, Rajiv Gandhi cancer institute and research centre, Sir Chotu Ram Marg, Rohini Institutional Area, Sector 5, Rohini, New Delhi, Delhi 110085
New Delhi
DELHI |
7065840893
mamcdeepti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, Rajiv Gandhi cancer institute and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D099||Carcinoma in situ, unspecified, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Plasma Lyte A |
Imported and marketed in India by Baxter India Pvt Ltd
Will be given intravenously
Frequency and dosing will be PVI regulated
Duration will be the intra-operative period between baseline ABG and ABG at the time of haemostasis |
| Comparator Agent |
Sterofundin ISO |
Manufactured and marketed by B. Braun Medical (I) Pvt Ltd
Will be given intravenously
Frequency and dosing will be PVI regulated
Duration will be the intra-operative period between baseline ABG and ABG at the time of haemostasis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing major onco-surgeries. |
|
| ExclusionCriteria |
| Details |
patients with significant renal, cardiac, or liver impairment, electrolyte imbalance in preoperative evaluation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pH and lactate levels in ABG |
At the start of surgery and at the time of haemostasis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate, mean blood pressure, total amount of crystalloid required, colloid requirement, blood replaced, |
Baseline, hourly intraoperatively till end of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Iv fluid is administered intra-operatively to maintain fluid and electrolyte haemostasis. This facilitates optimum tissue oxygen delivery. As serum lactate is a biomarker of severe tissue hypoperfusion, we compared the lactate levels at the end of surgery. Plasmalyte and Sterofundin are balanced crystalloid solutions that are routinely used in our institute in intraoperative period. Till now there are very few studies comparing the effect of these two on perfusion or acid base status. However no study has been done in major surgeries. |