An interventional study of Terlipressin and Norephrine in Acute on Chronic Liver Failure, sponsored by Institute of Liver and Biliary Sciences, India. Not yet recruiting at 1 site in India. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-08-16.
Sponsored by Institute of Liver and Biliary Sciences, India · Not applicable, Interventional, and Treatment
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Among 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India — 17 open to participants now, 17 under way, 2 of them phase 3. Acute-On-Chronic Liver Failure · Institute of Liver and Biliary Sciences, India.
Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, this one is the 9th largest by planned enrollment of the 28 interventional ones that give a count, is one of 4 that started in 2024, is one of 23 with no phase, reaches primary completion later than 3 of the 16 other live ones, and was the 29th registered.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
Browse Acute-On-Chronic Liver Failure studies →17 of the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India are open now, in 1 country. Recruiting first, the newest first:
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18+
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–75
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India · Sites in India
Ages 18–65
Institute of Liver and Biliary Sciences, India
Ages 18+
By country, each count listing its studies:
Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 60 Years · all sexes · no healthy volunteers.
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39 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 3
First in 2011; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 126 is above the median of 73 across 96 interventional studies indexed under Acute-On-Chronic Liver Failure.
Median enrollment 95 across the 28 interventional studies, 114 across the 11 observational. Of the 13 that completed or were terminated, 0 (0%) have results posted.
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Institute of Liver and Biliary Sciences, India is the lead sponsor of 302 studies on the registry; 87 are open to participants now.
4 of the studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06818565Institute of Liver and Biliary Sciences, IndiaComparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections. | 2026-12-31 |
| NCT07184866Institute of Liver and Biliary Sciences, IndiaVitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial | 2027-07 |
| NCT07178366Institute of Liver and Biliary Sciences, IndiaDouble Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial) | 2027-07 |
| NCT07422948Institute of Liver and Biliary Sciences, IndiaEfficacy and Safety of Early Initiation of Midodrine for Control and Prevention of Ascites and Its Related Complications in Acute-on-chronic Liver Failure. | 2027-08-30 |
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Among the 39 studies in Acute-On-Chronic Liver Failure by Institute of Liver and Biliary Sciences, India, from their registry updates:
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ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity \< 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.
At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.
Currently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.
Development of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.
Study population:
septic shock with AKI in patients of ACLF
Study design: Prospective open labelled randomised controlled study. The study will be conducted in Department of Hepatology ILBS- intensive care unit.
At admission:
Complete history and physical examination
Monitoring • Hemodynamic- MAP,HR, Urine output hourly
Stopping Rule
Salvage group • Patient Unwilling for Further Hospital Stay: • Non responders or when patient in either arm failed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg/24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively. 2. Norepinephrine will be initiated @0.05mcg/kg/min and titrated upto 0.5 mcg/kg/min to maintain a MAP \> 65 to 75 mm Hg. 3. IV albumin as per volume status to maintain target MAP . 4. If the target MAP is not achieved, a third vasopressor along with hydrocortisone, Adrenaline and then phenylephrine.
Drug: Terlipressin · Drug: Norephrine
1. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg/kg/min to 0.5 mcg/kg/min to maintain a MAP \> 65 to 75 mm Hg. 2. IV albumin as per volume status to maintain target MAP . 3. If the target MAP is not achieved, vasopressin along with hydrocortisone, followed by adrenaline and phenylephrine, may be added as a fourth vasopressor.
Drug: Norephrine
1. Patients in this group will receive continuous terlipressin infusion (1 mg/24 hr on day 1, increasing to 1 mg in 24 hours if target MAP not achieved ,reaching maximum terlipressin dose of 4 mg/24 hr on day 4).If target MAP not achieved by terlipressin dose ,increase noradrenaline dose keeping terlipressin maximum 1 mg ,2 mg ,3mg ,4mg at Day 1,2,3,4 respectively.
1. Patients in this group will receive norepinephrine only, with a dose range of 0.05 mcg/kg/min to 0.5 mcg/kg/min to maintain a MAP \> 65 to 75 mm Hg.
Proportion of patients developing 1 stage improvement in Acute kidney injury stage with resolution of shock at day 4 in both groups
Time frame: Day 4
Outcome of acute kidney injury at day 4,7
Outcome in terms of resolution, persistence or progreession
Time frame: Day 4 and 7
Incidence of adverse events in both groups
Time frame: 1 year
Need of renal replacement therapy at day 7
Time frame: Day 7
Duration of ICU and hospital stay
Time frame: 1 year
Mortality
Time frame: Day 7 and 28
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Aug 2025, 12 months later.
Of 32 interventional studies with no phase under Acute-On-Chronic Liver Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 50. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Terlipressin
Acute-On-Chronic Liver Failure →
Institute of Liver and Biliary Sciences, India →