Last reviewed · How we verify
NCT04819568
Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.
NA trial testing Terlipressin in Liver Cirrhosis in 310 participants. Status unknown.
19 March 2022
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 | 310 |
| Start date | 25 June 2021 |
| Primary completion | 19 March 2022 |
| Estimated completion | 19 March 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- Terlipressin — full drug profile →
- Standard of Care
Conditions studied
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 70, any sex, with Liver Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Septic shock is a major life-threatening vasodilatory shock. Vasopressor form a crucial pharmacotherapeutic option and have long been used as the first and foremost recommended therapy.(1) However, some patients may remain refractory to catecholamine, which is also known as catecholamine-resistant septic shock.(2, 3) High-dose catecholamine therapy may lead to potential side effects such as increased myocardial oxygen consumption, lethal arrthymias, and even the high risk of mortality. (4)Therefore, newer alternatives like dopamine, dobutamine, somatostatin, and terlipressin are also used. Cirrhosis is a state of hyperdynamic circulation, which worsens with the onset of infection. In septic shock, there is relative deficiency of vasopressin. (13) The mortality of septic shock in these patients still remains extremely high. Terlipressin is a synthetic vasopressin analogue with greater selectivity for the V1-receptors.(5) In cirrhotics with septic shock, terlipressin has been used either as a continuous intravenous infusion or as intravenous boluses. However, at present none of studies reveal which would be a better mode of administration in cirrhotics with septic shock considering the reversal of hemodynamics and safety of patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04819568
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Terlipressin
Trials testing the same drug.
- NCT07304466 — Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation · NA · not yet recruiting
- NCT06556472 — Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving · NA · not yet recruiting
- NCT03130127 — Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis · NA · unknown
- NCT06108362 — Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients · Phase 4 · unknown
- NCT05315557 — Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic · NA · unknown
Other recruiting trials for Liver Cirrhosis
Currently open trials in the same condition.
- NCT07439939 — Exploration of Systemic and Portal Hemostasis in Patients Undergoing Transjugular Intrahepatic Portosystemic Shunt Place · recruiting
- NCT07325526 — A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- · Phase 2 · recruiting
- NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
- NCT07201649 — Roles of Hepatic Insufficiency, Hepatic Fibrosis, and Inorganic Pyrophosphate in the Progression of Arterial Calcificati · NA · recruiting
- NCT07252102 — Effect of HFNC on Incidence of Hypoxia During Sedated Gastrointestinal Endoscopy in Critical Patients · NA · recruiting
Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
- NCT07480005 — To Revisit the Yield of Staging Laparoscopy in Hepatopancreatobiliary Malignancies · recruiting
- NCT07480057 — Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry · recruiting
- NCT07465471 — Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis. · NA · not yet recruiting
- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
- NCT07422948 — Efficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications · NA · not yet recruiting
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 NCT04819568 (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 November 2021
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/NCT04819568.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing