| CTRI Number |
CTRI/2024/05/067338 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the effect of Dexmedetomidine drug on postoperative renal function in patients undergoing valve surgery |
|
Scientific Title of Study
|
A Prospective Randomized Double blinded Comparative study to assess the effects of Dexmedetomidine on postoperative renal function in patients undergoing valve surgery under cardiopulmonary bypass in SMS Medical College Jaipur |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia,SMS Medical College and Hospital,JLN Marg ,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Verma |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia,SMS Medical College and Hospital,JLN Marg ,Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413622967 |
| Fax |
|
| Email |
dr.induverma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejaswini H J |
| Designation |
PG Resident |
| Affiliation |
Sawai Man Singh Medical College and Hospitals |
| Address |
Department of Anaesthesia, SMS Medical College and Hospitals,JLN Marg, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7022849113 |
| Fax |
|
| Email |
tejujothaiah33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, 2nd floor, Dhanvantari complex SMS Medical College and Hospitals, Jaipur |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospitals |
| Address |
Department of Anaesthesia,2nd floor, Dhanvantari complex, SMS Medical College, Jaipur, Rajasthan |
| 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 |
| Dr Indu Verma |
Cardiac OT, SMS Medical College and Hospitals |
Department of Anaesthesia, 2nd floor, Dhanvantari complex, SMS Medical College, Jaipur
Jaipur
RAJASTHAN |
9413622967
dr.induverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Ethics Committee, SMS Medical College, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I08||Multiple valve diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injection Dexmedetomidine |
Infusion of Inj Dexmedetomidine IV at 0.6MCG/kg/hr in 50 ml syringe 10 minutes before induction to 6 hours after surgery. |
| Comparator Agent |
Normal saline |
Infusion of Normal Saline at 0.6MCG/kg/hr in 50 ml syringe 10 minutes before induction to 6 hours after surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give consent.
2. Patients of 18 to 80 years of age scheduled for cardiac valve replacement/valvuloplasty with either a single valve or multiple valves under CPB.
3. ASA grade 2 and 3. |
|
| ExclusionCriteria |
| Details |
1.Non-cooperative patient.
2.Patients with BMI more than or equals to 30kg/m2.
3. Patients with pre-op pulmonary infection, liver insufficiency, kidney insufficiency.
4. Patients with history of use of nephrotoxic drugs and contrast agents used within 48 hours.
5. Patients with history of kidney or heart surgery. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Mean changes in renal function pre-op and post op 48 hrs after surgery by measuring Serum Creatinine and Blood Urea. |
Comparison of Mean changes in renal function pre-op and post op 48 hrs after surgery by measuring Serum Creatinine and Blood Urea. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of Mean changes in Intraoperative Haemodynamics (MAP and HR).
2.Comparison of Mean Changes in serum indices C reactive protein levels in both the groups.
3.Comparison of Mean Changes in postoperative recovery and incidence of complications. |
1.30min interval throughout surgery.
2.48 to 72 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| 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="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
|
Valvular heart disease is the most common structural heart disease and refers to the abnormal anatomic structure and function of the heart valve or peri valvular tissue caused by rheumatism, degeneration, infection, and congenital developmental malformations. AKI is a common complication with an estimated incidence about 7% to 45% in adult cardiac surgery.Dexmedetomidine, a highly selective alpha adrenoreceptor agonist, induces sedation, analgesia, hemodynamic stabilization, anti-inflammation, as well as diuresis. It’s perioperative administration could reduce AKI incidence in patients undergoing cardiac surgery. |