| CTRI Number |
CTRI/2024/09/073856 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out whether long duration surgeries has high rate of complications like lung congestion and kidney damage after the operation and to see if there is any role of intravenous fluids given during the operation in the occurrence of these complications. |
|
Scientific Title of Study
|
Incidence of postoperative pulmonary congestion and acute kidney injury in patients undergoing long duration surgeries and its correlation with intraoperative standard fluid therapy: a prospective observational study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anita Sharma |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Room no 9, department of Anaesthesia,Dr RPGMC Kangra at Tanda, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
09418921676 |
| Fax |
|
| Email |
anitasharma677@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Sharma |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Room no 9, department of Anaesthesia,Dr RPGMC Kangra at Tanda, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
09418921676 |
| Fax |
|
| Email |
anitasharma677@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anita Sharma |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Dr Rajendra Prasad Government Medical College Kangra at Tanda |
| Address |
Room no 9, department of Anaesthesia,Dr RPGMC Kangra at Tanda, Himachal Pradesh
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
09418921676 |
| Fax |
|
| Email |
anitasharma677@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anita Sharma |
| Address |
Room NO 9, Department of Anaesthesia, Dr RPGMC Kangra at Tanda(H.P) |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shallu Chaudhary |
Room NO 1, Department of Anaesthesia, Dr RPGMC Kangra at Tanda(H.P) |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anita Sharma |
Dr RPGMC Kangra at Tanda |
Room no 9, department of Anaesthesia,Dr RPGMC Kangra at Tanda, Himachal Pradesh
Kangra
HIMACHAL PRADESH |
09418921676
anitasharma677@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Rajendra Prasad Government Medical College(Dr.RPGMC) Kangra at Tanda,Himachal Pradesh, India-176001 Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The patients of ASA grade I–II who will be
undergoing long surgery of duration more than 3 hours |
|
| ExclusionCriteria |
| Details |
Patients with preexisting heart and pulmonary diseases, morbid obesity, pregnancy, surgery duration less than 3 hours, urologic surgery, cardiac surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To calculate the incidence of postoperative pulmonary congestion by using lung ultrasound and incidence of postoperative AKI by using renal function tests serum creatinine more than 0.3mg/dl |
Lung ultrasound performed 1 hour after surgery and renal function tests performed 5 days after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To correlate the total intravenous fluids, blood and blood products administered intraoperatively with the incidence of pulmonary congestion and acute kidney injury |
1 hour after the surgery and 5 days after the surgery |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
21/09/2024 |
| 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="0"
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
|
This study will be a prospective, single center, observational study to be carried out for a period of one year. Patients of the age group of 18 to 65 years, ASA I and II, undergoing long duration surgery of more than 3 hours will be included in the study. Patients with cardiovascular ailments, morbid obesity, pregnancy, undergoing cardiothoracic and urologic surgery will be excluded from the study. Lung ultrasound will be performed preoperatively and 1 hour postoperatively by the the same experienced investigator to avoid inter variability. The renal function test will be performed preoperatively and 5 days post operatively. The primary outcome is to calculate the incidence of postoperative pulmonary congestion and acute kidney injury. The secondary outcome is to see the correlation of total intravenous fluids, blood and blood products administered intraoperatively with postoperative pulmonary congestion and acute kidney injury. |