| CTRI Number |
CTRI/2025/08/092559 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [THERAPEUTIC] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out if using low doses of a medicine called terlipressin, along with albumin, can help prevent kidney problems in patients with septic shock |
|
Scientific Title of Study
|
Effect of low-dose Terlipressin with Albumin on Major Adverse Kidney Events in patients with Septic Shock: A Randomised Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKIT GOYAL |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Anaesthesia, pain medicine and critical care, AIIMS, New Delhi
5th floor, academic block building
DELHI
110029
India |
| Phone |
9872354351 |
| Fax |
|
| Email |
goyalankit1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIMI REWARI |
| Designation |
PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Anaesthesia, pain medicine and critical care, AIIMS, New Delhi
5th floor, academic block building
New Delhi
DELHI
110029
India |
| Phone |
9872354351 |
| Fax |
|
| Email |
vimirewari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKIT GOYAL |
| Designation |
Senior Resident |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
| Address |
Department of Anaesthesia, pain medicine and critical care, AIIMS, New Delhi
5th floor, academic block building
New Delhi
DELHI
110029
India |
| Phone |
9872354351 |
| Fax |
|
| Email |
goyalankit1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI |
| Address |
DEPARTMENT OF ANAESTHESIA AND CRITICAL CARE, 5TH FLOOR, ACADEMIC BLOCK, AIIMS, NEW DELHI |
| 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 |
| ANKIT GOYAL |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
DEPARTMENT OF ANAESTHESIA, PAIN MEDICINE AND CRITICAL CARE, ACADEMIC BLOCK, 5TH BLOCK, AIIMS, New Delhi
New Delhi
DELHI |
09872354351
goyalankit1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LOW DOSE TERLIPRESSIN AND ALBUMIN |
LOW DOSE TERLIPRESSIN INFUSION(1MCG/KG/HR) FOR 48 HOURS ALONG WITH ALBUMIN INFUSION (20 GMS/25HR) FOR 48 HOURS WILL BE GIVEN TO SEPTIC SHOCK PATIENTS IN THE INTERVENTION GROUP |
| Comparator Agent |
NORADRENALINE WITH OR WITHOUT SECOND AND THIRD LINE VASOPRESSORS FOR SEPTIC SHOCK |
NORADRENALINE INFUSION TITRATED TO KEEP MEAN BLOOD PRESSURE MORE THAN SIXTY FIVE MILLIMETER OF MERCURY WITH OR WITHOUT SECOOND AND THIRD LINE VASOPRESSORS FOR SEPTIC SHOCK IN TITRATED DOSES |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with septic shock |
|
| ExclusionCriteria |
| Details |
LATE STAGES OF SHOCK PREGNANCY LACTATION ADVANCED CARDIAC DISEASE ADVANCED KIDNEY DISEASE ADVANCED LIVER DISEASE PERIPHERAL VASCULAR DISEASE SOLID ORGAN TRANSPLANT PATIENTS SEVERE HYPOXEMIA HIGH DOSE VASOPRESSORS ACUTE KIDNEY INJURY STAGE THREE OR MORE |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of MAKE30 (Major adverse kidney events within 30 days) – defined as a composite outcome of KIDIGO stage 3, or death, or both, within 30 days |
Incidence of MAKE30 (Major adverse kidney events within 30 days) – defined as a composite outcome of KIDIGO stage 3, or death, or both, within 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in NGAL level Incidence of SA-AKI
Mean SOFA Mean renal SOFA score
Renal failure free days
Hemodialysis free days
Organ failure free days
ICU free days
Length of hospital stay
Dialysis dependency
adverse events attributable to terlipressin & albumin Net fluid balance
|
Baseline 30DAYS 3MONTHS |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Low dose terlipressin infusion at one micrograms per kg per hour along with albumin infusion at twenty grams in twenty four hours for first forty eight hours are expected to decrease the incidence of major adverse kidney events in thirty days in septic shock patients including decreased mortality decreased incidence of persistent renal dysfunction and decreased need of renal replacement therapy after thirty days of onset of septic shock |