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Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine/Octreotide | Experimental | oral midodrine plus octreotide as subcutaneous injection |
|
| Nor-epinephrine | Active Comparator | Intravenous infusion norepinephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine/Octreotide | Drug | oral midodrine plus octreotide as subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Full response | the proportion of patients achieved full response defined as return of serum creatinine to a value within 0.3 mg/dl of the baseline value | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Partial response | defined as a regression of at least one acute kidney injury stage with a fall in the serum creatinine value to ≥0.3 mg/dl above the baseline serum creatinine value | 10 days |
| Reversal |
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Inclusion Criteria:
Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria
Exclusion Criteria:
Serum creatinine (sCr) >7 mg/dL Hypotension (mean arterial pressure (MAP) <70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications
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| Name | Affiliation | Role |
|---|---|---|
| Doaa Abdelaziz yousef, Ph.D | Fellow at The National Hepatology and Tropical Research medicine institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The National Hepatology and Tropical Research medicine institute | Cairo | Egypt |
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| ID | Term |
|---|---|
| D006530 | Hepatorenal Syndrome |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| D015282 | Octreotide |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Nor-epinephrine | Drug | Intravenous infusion norepinephrine |
|
|
Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment.
| 10 days |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000588 |
| Amines |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |