NCT03455322

Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.

Pros & Cons of Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1 in Intensive Care Unit.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Hepatology & Tropical Medicine Research Institute · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aimed to investigate the efficacy of midodrine plus octreotide versus norepinephrine and to determine the predictive factors of response in patients with HRS-AKI.

Detailed description

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 \[2\] were eligible for participation. Screening and eligibility criteria were verified upon admission to the ICU. A diagnosis of AKI was established through comparing sCr value at time of ICU admission to that recorded in the patient's file. Patients who meet all other diagnostic criteria of HRS-AKI provided by the previous definition \[2\] were enrolled in the study. Qualified patients were subjected to baseline assessments after informed consent signature. It included vital sign measurements, presence of comorbidities, height and weight, Child-Pugh score and Sequential Organ Failure Assessment (SOFA) score. Vital signs, Blood urea nitrogen, sCr, serum sodium, serum albumin, total bilirubin, and complete blood count with differential were measured at baseline and at daily basis throughout the study period. Patients were randomized in a 1:1 ratio to receive either continuous infusion of norepinephrine in an initial dose of 0.5mg/h (Maximum 3 mg/h or oral midodrine 5mg three times/day (Maximum 12.5mg three times/day) plus octreotide 100μg/6h as subcutaneous injection (Maximum 200 μg/6h). Duration of treatment was allowed to extend to a maximum of 10 days. Administration of albumin at doses of 20 to 40 gm/day was recommended, as clinically indicated, for all patients in both study arms as per current ICA guidelines.

Conditions

• Renal Impairment in Hepatorenal Syndrome

Interventions

Type	Name	Description
DRUG	norepinephrine versus midodrine & octreotide	either intravenous infusion (IVi) norepinephrine in a dose of 0.05-0.3ug/Kg/min. to keep mean arterial pressure ≥ 80-100mmHg \& continued either until HRS reversal or for maximum 10 days or oral midodrine 5mg three times/day \& can be increased every 24h up to 12.5mg three times daily plus octreotide 100ug/ 6h subcutaneous \& if needed increased to 200ug/6h.

Timeline

• Start date: 2018-08-15
• Primary completion: 2020-04-20
• Completion: 2020-07-10
• First posted: 2018-03-06
• Last updated: 2021-02-23

Locations

1 site across 1 country: Egypt