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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

Effect of low-dose Terlipressin with Albumin on Major Adverse Kidney Events in patients with Septic Shock: A Randomised Controlled Trial - NIL

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092559
Enrollment
116
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B998- Other infectious disease

Interventions

Intervention1: 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

Sponsors

ALL INDIA INSTITUTE OF MEDICAL SCIENCES NEW DELHI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with septic shock

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 daysTimepoint: 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

MeasureTime frame
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 Timepoint: Baseline 30DAYS 3MONTHS

Countries

India

Contacts

Public ContactANKIT GOYAL

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI

vimirewari@gmail.com9872354351

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026