| CTRI Number |
CTRI/2024/10/075534 [Registered on: 18/10/2024] Trial Registered Prospectively |
| Last Modified On: |
17/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Early Intraoperative Administration of drug increasing blood pressure on Organ Dysfunction after abdominal surgery |
|
Scientific Title of Study
|
Early Vasopressor Administration And Postoperative Organ Dysfunction In Elective Abdominal Surgery: A Randomized Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Kumar Anand |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room No 5020,5th floor , Department of Anaesthesiology , Pain Medicine and Critical Care,AIIMS, New Delhi
South DELHI 110029 India |
| Phone |
9013082271 |
| Fax |
|
| Email |
drrahulkanand@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Rahul Kumar Anand |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room No 5020,5th floor , Department of Anaesthesiology , Pain Medicine and Critical Care,AIIMS, New Delhi
South DELHI 110029 India |
| Phone |
9013082271 |
| Fax |
|
| Email |
drrahulkanand@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Divya N |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Room No 5011,5th floor , Department of Anaesthesiology , Pain Medicine and Critical Care,AIIMS, New Delhi
South DELHI 110029 India |
| Phone |
9486463472 |
| Fax |
|
| Email |
divy4499@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi, Ansari Nagar 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care,AIIMS New Delhi, Ansari Nagar ,New Delhi 110029 |
| 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 |
| DrRahul Kumar Anand |
AIIMS New Delhi |
AB8,Department of Anaesthesiology , Pain medicine and Critical Care,8th floor,Ward Block,All India Institute of Medical Sciences New Delhi,Ansari Nagar South DELHI |
9013082271
drrahulkanand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Comittee |
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 |
| Intervention |
Early Noradrenaline infusion |
The study will follow the standard hospital procedures and protocols for surgery, anaesthesia, and perioperative care. All patients will undergo invasive arterial pressure monitoring, in addition to standard ASA monitoring. undergo standard management under anaesthesia, the only exception being immediate initiation of noradrenaline infusion at 0.1 mcg/kg/min at the onset of hypotension (defined as fall in MAP 20% from baseline or fall to less baseline or Hg). Noradrenaline dose will be titrated to maintain MAP within 20% of baseline.After surgery patient will be shifted toward/ HDU/ ICU depending upon the clinical status of the patient. Management of the postoperative period will be as per standard department protocol.Duration of intervention till the time of surgery |
| Comparator Agent |
Standard Treatment Protocol |
In case of hypotension, the decision to give fluid boluses or vasopressors (either as bolus or as infusion) will depend solely on the clinical judgement of the anaesthesiologist guided by stroke volume variation/ pulse pressure variation (Edward 1000 Volumeview). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 70 years undergoing elective major open abdominal surgery with general anaesthesia with expected surgical duration of more than 120 minutes |
|
| ExclusionCriteria |
| Details |
1)Patients who decline to give consent.
2)Patients with poorly controlled hypertension
3)K/c/o CAD, CKD, CLD
4)Patients with primary end organ dysfunction.
5)Patients on monoamine oxidase inhibitors
6)Patients who were pregnant or breastfeeding.
7)Patients with phaechromocytoma/paraganglionoma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the difference in severity of organ dysfunction in the first seven postoperative days between the two groups using the mean SOFA score |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in the individual components of the primary outcome |
7 days |
| Difference in total fluid infused |
24 hours |
| Difference in intraoperative blood loss |
Duration of surgery |
| Difference in cumulative fluid balance at Day7 |
7 days |
| Difference in lactate levels lactate level at end of surgery, 24 post-op |
at the end of surgery , 24 hours |
| P/F ratio at end of surgery and at 24h post op |
at the end of surgery , 24 hours |
| Difference in 28-day mortality between the groups |
28 days |
| Difference in unplanned ICU stay between the groups. |
28 days |
| Difference in length of hospital stay between the groups |
Day 28 |
| Difference in duration of mechanical ventilation |
28 days |
| Difference in incidence of AKI |
28 days |
| Difference in organ failure free days (no need for vasopressors, NIV/IMV or RRT) |
28 days |
| Difference in mean I-FEED score at day 7 and time to GI-2 recovery |
7 days |
|
|
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 4 |
|
Date of First Enrollment (India)
|
28/10/2024 |
| 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
|
Intraoperative hypotension is common side effect of general anaesthesia. It has a multifactorial aetiology and associates with increased mortality, stroke, cardiac morbidity, acute kidney injury, and delirium. Even mild hypotension is potentially deleterious. As the blood pressure threshold decreases, the risk of injury increases, and appears to occur with a much shorter duration.Maintenance of adequate BP and organ perfusion is, therefore, a key priority in the perioperative period. Current strategies include intravenous (IV) fluids and vasopressors. Norepinephrine, a mixed α1 and β1-adrenergic agonist, offers a favourable pharmacological profile to maintain BP in the perioperative setting. Thus, administration of norepinephrine may provide an effective strategy to safely achieve and maintain BP thresholds and prevent or attenuate hypotension in the intra- and postoperative period.The sequential organ failure assessment (SOFA) score is a simple and objective scoring system that represents degree and progression of dysfunction with a four-point assessment for each of the six organ systems (central nervous system, cardiovascular system, respiratory system, renal system, liver and coagulation). This assessment was initially developed to describe and quantify organ function and has been validated in various clinical situations. An increase in the SOFA score during ICU treatment has also been associated with progressive organ failure and increased mortality in various clinical settings . Perioperative administration of vasoactive drugs may reduce postoperative complications and hospital length of stay in adult patients having major abdominal surgery and length of hospital stay.In this study, We aim to determine the association between the mean SOFA score for 7 days and postoperative outcomes in patients who have early administration of noradrenaline for intraoperative hypotension during major abdominal surgery. | |