| CTRI Number |
CTRI/2024/01/061803 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
12/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Blood pressure control during major surgery and outcomes |
|
Scientific Title of Study
|
Impact of targeted blood pressure management versus standard care amongst patients undergoing major abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrLakshmi Kumar |
| Designation |
Professor and HOD |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 6 Floor 1
Department of Anaesthesia
AIMS Kochi
Ernakulam
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
4842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrLakshmi Kumar |
| Designation |
Professor and HOD |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Tower 6 Floor 1
Department of Anaesthesia
AIMS Kochi
KERALA
682041
India |
| Phone |
9496211333 |
| Fax |
4842852020 |
| Email |
lakshmi.k.238@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMadhubala Venkatesan |
| Designation |
Post graduate student |
| Affiliation |
Amrita Institute Of Medical Sciences Kochi |
| Address |
Tower 6 Floor 1
Department of Anaesthesia
AIMS Kochi
Ernakulam
KERALA
682041
India |
| Phone |
8939745673 |
| Fax |
4842852020 |
| Email |
madhuvenkat9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences Kochi |
|
|
Primary Sponsor
|
| Name |
Amrita institute of Medical Sciences |
| Address |
Amrita lane
Edapally
Kochi 682041 |
| Type of Sponsor |
Private 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 |
| DrLakshmi kumar |
Amrita Institute of Medical Sciences |
Department of Anaesthesia
Tower 6 Floor1
AIMS Kochi
Ernakulam
KERALA |
9496211333
4842852020
lakshmi.k.238@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard care in blood pressure management based upon MAP |
Mean arterial pressure is to be maintained above 65 mm Hg through out the surgery. Norepinephrine will be used if MAP falls below 65 mm Hg |
| Intervention |
Targeted mean arterial pressure (MAP) management |
After baseline MAP is obtained, propofol or fentanyl will be used to reduce and nor epinephrine infusion to maintain the MAP with the target range of 20 % of the baseline MAP |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
72.00 Year(s) |
| Gender |
Both |
| Details |
ASA II and above patients above 45 years
with one of the following
1. Coronary artery disease
2. NIDDM
3. cerebrovascular accident
4. peripheral vascular disease
undergoing major abdominal surgery lasting more than 4 hours
|
|
| ExclusionCriteria |
| Details |
1.emergency surgery
2.Preoperative ventilation or COPD
3.Renal dysfunction creatinine more than 1.5
4.CAD EF less than 35%
5.AST ALT more than twice normal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Any organ dysfunction 24 hours postoperatively
1 Renal as per RIFLE criteria
2 Elevated hsTropT
3 Respiratory SpO2 less than 94 or need for respiratory assist devices
4 Neurological GCS less than 14
5 Coagulation Platelet INR as per SOFA |
24 hours postoperatively in the ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of ICU stay
Length of hospital stay
SOFA scores |
SOFA during IU stay only |
|
|
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)
|
29/01/2024 |
| 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="2"
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
|
We aim to evaluate the impact of a targeted blood pressure management within 20 % of baseline value amongst high risk patients undergoing major abdominal surgery. The impact is to be assessed by looking for evidences of any organ dysfunction, cardiac, renal, respiratory, coagulopathy or neurological outcomes.
This may provide us insights on the benefits ofa targeted blood pressure management amongst high risk patients undergoig abdominal surgery |