| CTRI Number |
CTRI/2024/06/068535 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
18/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the efficacy of medications that increases blood pressure that is Noradrenaline alone versus Noradrenaline plus Terlipressin in two groups of patients in ICU who admitted with profound low blood pressure following infection. |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF NORADRENALINE ALONE VERSUS NORADRENALINE AND TERLIPRESSIN FOR MANAGEMENT OF SEPTIC SHOCK IN ICU: A PROSPECTIVE 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 |
DR ALTAFUDDIN AHMED |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TEZPUR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY TEZPUR MEDICAL COLLEGE AND HOSPITAL TUMUKI
Sonitpur
ASSAM
784010
India |
| Phone |
9435032380 |
| Fax |
|
| Email |
draltafahmeddbr@Yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ALTAFUDDIN AHMED |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TEZPUR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY TEZPUR MEDICAL COLLEGE AND HOSPITAL TUMUKI
Sonitpur
ASSAM
784010
India |
| Phone |
9435032380 |
| Fax |
|
| Email |
draltafahmeddbr@Yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ALTAFUDDIN AHMED |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TEZPUR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY TEZPUR MEDICAL COLLEGE AND HOSPITAL TUMUKI
Sonitpur
ASSAM
784010
India |
| Phone |
9435032380 |
| Fax |
|
| Email |
draltafahmeddbr@Yahoo.in |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY TEZPUR MEDICAL COLLEGE AND HOSPITAL TUMUKI BIHAGURI 784010 SONITPUR ASSAM |
|
|
Primary Sponsor
|
| Name |
TEZPUR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY TEZPUR MEDICAL COLLEGE AND HOSPITAL TUMUKI BIHAGURI 784010 SONITPUR ASSAM |
| 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 |
| MOIRANGTHEM DHANAPIYARI DEVI |
TEZPUR MEDICAL COLLEGE AND HOSPITAL |
Intensive Critical Care Unit, Department of Anaesthesilogy
Sonitpur
ASSAM |
08822898572
dhanapriyamoirangthem@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B948||Sequelae of other specified infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Noradrenaline |
Group 2 patients will received Noradrenaline 0.01-3 mcg/kg/minute infusion. The dose of noradrenaline will be titrated to achieve the target mean arterial blood pressure of 65-70 mmHg. The dose of noradrenaline require to achieve the target blood pressure after 12 hours of starting the infusion will be recorded. |
| Intervention |
Noradrenaline plus Terlipressin |
Participants will be recruited and randomized using computer created random number technique using the allocation ratio 1:1. Group 1 patients will received combination of Terlipressin 0.01mcg/kg/minute (fixed dose) and Nordarenaline 0.01-3mcg/kg/minute infusion.Dose of Noradrenaline can be titrated to achieve the target mean arterial blood pressure of 65-70mmHg. The dose of Noradrenaline required to achieve target mean arterial blood pressure of 65-70mmHg after 12 hours of starting the infusion will be recoreded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patient with septic shock presenting with mean arterial pressure less than 65 mmHg despite appropriate volume resuscitation. |
|
| ExclusionCriteria |
| Details |
Patient age less than 18 years, presence of severe comorbid conditions, requirement of any other vasopressor, need of more than 3 mcg/kg/minute of noradrenaline infusion to achieve the target mean arterial pressure. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of starting infusion. |
Dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of starting infusion. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Length of ICU stay
Duration of vasopressor requirement
Changes in the lactate levels in 12 hours post-initiation of vasopressor infusion.
Urine output in ml/hour at 12 hours post-initiation of the vasopressor infusion.
Changes in the qSOFA score at 12 hours post initiation of vasopressor infusion.
Incidence of serious adverse events like digital ischaemia, cardiac arrythmias, incidence of diarrhoea and upper GI bleed. |
12 hours |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Sepsis is defined as a life threatening organ dysfunction caused by a dysregulated host response to infection. Vasoactive drugs are important to maintain the stability of hemodynamics and ensure the perfusion of major organs. Noradrenaline is the first line of drug for septic shock.The aim of the study is to compare noradrenaline alone versus noradrenaline and terlipressin combined in the management of septic shock in ICU. The study will be conducted in the central intensive care unit, Tezpur Medical College and Hospital for a period of 1 year which is a prospective randomized controlled study. The study will include patient age more than 18 years with septic shock presenting with mean arterial pressure <65 mmHg despite appropriate volume resuscitation. The participants will be recruited and randomized by using computer created random number technique using the allocation ratio 1:1. Group 1 patients will received terlipressin 0.01 mcg/kg/min ( fixed dose infusion) and infusion noradrenaline 0.01-3 mcg/kg/min and group 2 patients will received infusion noradrenaline 0.01-3 mcg/kg/min. Primary outcome is to measure the dose of noradrenaline require to achieve target mean arterial pressure of 65-70 mmHg after 12 hours of infusion. And secondary outcomes are to measure the length of ICU stayed, duration of vasopressor requirement, changes in the serum lactate level, urine output in ml/hour, changes in qSOFA in 12 hours post-initiation of infusion and incidence of serious adverse events like digital ischaemia, cardiac arrythmias, diarrhoea and upper GI bleed. |