Not provided
Not provided
Not provided
Not provided
Not provided
lack of funds
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
All consecutive patients with liver cirrhosis having Acute Kidney Injury at admission or during hospitalization will be included in the study.
The diagnosis of liver cirrhosis will be based on the clinical grounds including Laboratory tests, endoscopic evidence, imaging (Ultrasonography/computed tomography) findings, and liver histology, when available.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nor adrenaline and terlipressin | Experimental |
| |
| step up terlipressin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nor adrenaline and terlipressin | Drug | IV bolus terlipressin at the dose of 0.5 to 1 mg every 6 hours with the maximum daily cumulative dose of 4 mg/day. Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours in case of no response.[ No response defined as MAP < 10, or 4 hr Urine output < 200 ml] with maximum dose upto 3 mg/h. |
| Measure | Description | Time Frame |
|---|---|---|
| the Response to treatment in each intervention group | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 15 days | |
| Side effects of the drug | 3 months | |
| Complications and the predictors of the treatment response |
Not provided
Inclusion Criteria:
- Patients with Liver cirrhosis and acute kidney injury. Patients consented for the study protocol by signing the informed consent.
Exclusion Criteria:
- Age less than 18 years Cirrhotics with kidney injury managed as outpatients. Patients undergoing renal replacement therapy (hemodialysis/renal transplantation).
Post liver transplantation patients. Hepatocellular carcinoma. History of coronary artery disease, ischaemic cardiomyopathy, ventricular arrhythmia, or peripheral vascular disease.
Patients with obstructive uropathy. Patient who withdrew or non complaint to the study protocol.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| step up terlipressin therapy | Drug | IV bolus terlipressin starting at 1.5 mg every 6 hours with increase in dose by 0.5 mg/6 hours in case of no response [< 25% decrease in s.creatinine] after every 48 hours. Maximum daily cumulative dose of 12 mg/day. |
|
| 2 years |
| ID | Term |
|---|---|
| D006530 | Hepatorenal Syndrome |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D000077585 | Terlipressin |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
Not provided
Not provided