| CTRI Number |
CTRI/2020/11/028876 [Registered on: 04/11/2020] Trial Registered Prospectively |
| Last Modified On: |
01/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different types of fluid therapy in plastic reconstruction surgery |
|
Scientific Title of Study
|
Impact of goal-directed versus liberal fluid therapy on flap outcome in micro vascular free flap reconstructive surgery : a randomised controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhruvajyoti sengupta |
| Designation |
Post graduate trainee |
| Affiliation |
Government medical college |
| Address |
Department of anaesthesia
IPGMER and sskm hospital ajc Bose road kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
9903182918 |
| Fax |
|
| Email |
dhruva.sengupta1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sarbari swaika |
| Designation |
Professor |
| Affiliation |
Government medical college |
| Address |
Department of anaesthesia
IPGMER and sskm hospital ajc Bose road kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8420405962 |
| Fax |
|
| Email |
Dr.s.swaika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sarbari swaika |
| Designation |
Professor |
| Affiliation |
Government medical college |
| Address |
Department of anaesthesia
IPGMER and sskm hospital ajc Bose road kolkata
Kolkata
WEST BENGAL
700020
India |
| Phone |
8420405962 |
| Fax |
|
| Email |
Dr.s.swaika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia IPGMER and sskm hospital Kolkata |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
IPGMER and sskm hospital ajc Bose road kolkata |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Sarbari swaika |
IPGMER and sskm hospital |
Department of anaesthesia
Kolkata
WEST BENGAL |
8420405962
Dr.s.swaika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ipgmer research oversight committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C140||Malignant neoplasm of pharynx, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Goal directed fluid therapy |
Restricting fluid administration to a patient undergoing micro vascular free flap surgery using goal directed fluid therapy methods |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Nyha class 1 - 3
Albumin > 2.5 gm/dl
Weight 55 kg - 100 kg
Operation duration > 120 min
Blood loss > 1000 ml
|
|
| ExclusionCriteria |
| Details |
Cognitive limitations
Ejection fraction < 30%
Patients with active cardiac dysrhythmia
Pulmonary disease expected to prevent 8cc/kg tidal volumes
Sleep apnea
Renal disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the differences in intraoperative fluid administered for maintaining haemodynamic stability in case and control groups |
Intraoperative and 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the status of flap outcome post operatively for venous congestion,haematoma evacuation and reanaestomosis |
48 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/11/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Proper restriction of fluid administration during intraoperative period using goal directed fluid therapy strategies would lead to better haemodynamic stability leading to better patient and flap outcome postoperatively. |