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NCT06076330
Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension
NA trial testing 20% Albumin in Liver Cirrhosis in 120 participants. Status unknown.
31 August 2024
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 30 September 2023 |
| Primary completion | 31 August 2024 |
| Estimated completion | 31 August 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- 20% Albumin — full drug profile →
- 5% Albumin — full drug profile →
- Plasmalyte — full drug profile →
Conditions studied
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 75, any sex, with Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cirrhotic patients with sepsis represent a very sick subset of patients and septic shock in such patients is associated with high mortality. Early initiation of intravenous fluids and antibiotics is the key to management in these patients. The choice of fluid in cirrhotic patients with sepsis induced hypotension has been studied in the past. The choice of fluid, crystalloid vs colloid, for resuscitation in such patients has been a matter of debate. In the previous study, the ALPS trial, 20% albumin use was associated with a better reversal of hypotension but was associated with an increased incidence of pulmonary complications and 5% albumin was better when compared to normal saline(FRISC study) for fluid resuscitation. No study in the past has evaluated 5% albumin against 20% albumin in combination with crystalloid. Investigator aim to study the efficacy and safety of 20% albumin with plasmalyte against 5 % albumin for fluid resuscitation in cirrhotic patients with sepsis induced hypotension.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06076330
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other trials of 20% Albumin
Trials testing the same drug.
- NCT05357339 — Microcirculation Properties of Albumin for Fluid Resuscitation in Septic Shock · NA · completed
- NCT02721238 — Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis In · NA · completed
- NCT02788240 — To Study the Influence of GCSF on Natural History of Acute On Chronic Liver Failure After the Acute Phase · NA · terminated
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Currently open trials in the same condition.
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Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06076330 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 10 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06076330.
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