| CTRI Number |
CTRI/2024/06/068541 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Time weighted average(TWI)spent by patients ,study group(using hypotensive predictive index algorithm moniter) and control group(using standard cardiac output moniter) to prevent hypotension while undergoing major abdominal surgeries |
|
Scientific Title of Study
|
To compare hypotension predictive index and standard cardiac output monitoring in preventing hypotension in 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 |
Dr Premlal Sreekumar |
| Designation |
junior Resident |
| Affiliation |
Atal Bihari Vajpayee Medical university |
| Address |
Dept of Anaesthesia,command hospital ,central command, Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
-7085870057 |
| Fax |
|
| Email |
psreekumar.984p@gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr(Col) Shaleen Trivedi |
| Designation |
HOD Department of Anaesthesia |
| Affiliation |
|
| Address |
Dept of Anaesthesia,command hospital ,central command, Lucknow
Dept of Anaesthesia,command hospital ,central command, Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
-7085870057 |
| Fax |
|
| Email |
shaleen1974@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Premlal Sreekumar |
| Designation |
junior Resident |
| Affiliation |
Atal Bihari Vajpayee Medical University |
| Address |
Dept of Anaesthesia,command hospital ,central command, Lucknow
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
-7085870057 |
| Fax |
|
| Email |
psreekumar.984p@gov.in |
|
|
Source of Monetary or Material Support
|
| Command Hospital, Central Command,Lucknow,Uttar pradesh, India.pin 691008 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Dept of Anaesthesia,command hospital ,central command, Lucknow,India.pin 691008 |
| 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 |
| Dr Shaleen Trivedi |
Command hospital central command |
Dept of Anaesthesia, Command Hospital, Central Command
Lucknow
UTTAR PRADESH |
8334037888
shaleen1974@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Command Hospital Central Command |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: K958||Complications of other bariatric procedure, (3) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (4) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, (5) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
The control group (HPI unguided group) |
• Hemodynamic management will be based on the hemodynamic parameters provided by the conventional haemodynamic monitor with flotrac sensor, including cardiac index (CI) and stroke volume variation (SVV).
• If SVV increases above 13%, a crystalloid bolus of 4ml/kg body weight will be administered.
• MAP will be maintained above 65mm Hg by a vasoconstrictor drug when SVV 13 and CI 2.5 l/min/m sq
• An ionotropic agent will be added if the CI persists 2.5L/min/m sq
|
| Intervention |
The study group (HPI guided group) |
• Hemodynamic management will be based on the hemodynamic parameters provided by the HemoSphere platform with the Acumen IQ sensor, including CI, SVV.
• Acumen IQ specific parameters: maximum arterial pressure rise (dP/dtmax), dynamic arterial elastance (Eadyn) and HPI.
• The hemodynamic optimization algorithm on the intervention group is based on the three main mechanisms leading to arterial hypotension: hypovolemia, impaired contractility and vasoplegia.
• When HPI rises above 85, SVV will be checked.
• If SVV is 13%, SVI drops less than 10%, and Eadyn 0.8, a vasoconstrictor will be administered, if dP/dt max value is 600mmHg/s
• An inotrope if dP/dt max is 600mmHg/S.
• If SVV 13%, 4ml/kg body wt crystalloid bolus will be administered [17] if the Eadyn value is 1, or a vasoconstrictor if Ea dyn
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Age of subject 18 years and above
2) Scheduled for elective major abdominal surgery.
3) ASA grade II – IV
4) Need for continuous invasive blood pressure monitoring.
|
|
| ExclusionCriteria |
| Details |
1)Patients with significant hypotension as measured before surgery.
2) patients with known left or right cardiac failure, known arrythmias (e.g., atrial fibrillation), cardiac shunts, severe aortic stenosis or the need for dialysis will be excluded.
3) If surgery included clamping of the aorta or Pringle’s manoeuvre, the patient is not eligible for the trial.
4) Finally, emergency procedures will also be excluded from the trial |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| determination of time weighted average(TWA) spent by the study group and control group in the trial |
Time weighted average will be calculated soon after the end of Anaesthesia for the specific surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Determination of the incidence of intraoperative hypotension, i.e. the number of hypotensive events, total time (in minutes) spent with hypotension & the percentage of time spent in hypotension during surgery.
2) Determining the effect of hypotensive episodes & its duration & its effect on postoperative mortality (28 days) in form of myocardial ischemia, & acute kidney injury (AKI) as well as prolonged stay in ICU
|
1)KDIGO classification of AKI as SCr0.3 mg/dl from baseline within 48 hours,
1.5 times the baseline SCr within 7 days, or urine output less than 0.5
ml/kg/hr for more than 6 hours of urine output will be used to assess intraop
and postop AKI occurrence.
2) ECG will be done pre op, post op at 24 hrs & 48 hrs respectively to detect
any early changes of myocardial ischemia.
3) Pt/primary relative will be contacted telephonically to confirm about morbidity/mortality at 28 days postop. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
20/06/2024 |
| 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="1"
Months="5"
Days="26" |
|
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
|
To compare Hypotension predictive index and standard cardiac output monitering in preventing hypotension in major abdominal surgeries. To measure the time weighted average(TWA) spent in hypotension by the study and control group To determine the incidence of intra operative hypotension. To determine postoperative mortality in form of myocardial ischemia ,Acute kidney injury and prolonged ICU stay in relation to intraoperative hypotensive episode and its duration
|