A Phase 4 interventional study of norepinephrine versus midodrine & octreotide in Renal Impairment in Hepatorenal Syndrome, sponsored by National Hepatology & Tropical Medicine Research Institute. Completed at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by National Hepatology & Tropical Medicine Research Institute · Phase 4, Interventional, and Treatment
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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.
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.
50 studies on the registry are indexed under Hepatorenal Syndrome; 7 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 36 interventional studies indexed under Hepatorenal Syndrome.
Browse Hepatorenal Syndrome studies →National Hepatology & Tropical Medicine Research Institute is the lead sponsor of 20 studies on the registry; 6 are open to participants now.
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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 reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
norepinephrine continuous intravenous infusion in a dose of 0.05-0.3ug/Kg/min. average7-10 days to keep mean arterial pressure ≥ 80-100mmHg \& continued either until HRS reversal or for maximum 10 days.
Drug: norepinephrine versus midodrine & octreotide
midodrine 5mg three times/day orally \& can be increased every 24h up to 12.5mg three times daily plus octreotide 100ug/ 6h subcutaneous \& if needed increased to 200ug/6hS.C. for 7-10 days
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.
the proportion of patients achieved full response
defined as return of sCr to a value within 0.3 mg/dl of the baseline value
Time frame: within10 days
the proportion of patients achieved partial response
defined as a regression of at least one AKI stage with a fall in the sCr value to ≥0.3 mg/dl above the baseline value
Time frame: within 10 days
Incidence of HRS reversal
defined as at least one sCr value of ≤ 1.5 mg/dl while on treatment
Time frame: within 10 days
incidence of HRS-AKI relapse
relapse of HRS-AKI after cessation of treatment
Time frame: 30 days
overall survival
patients who are survived
Time frame: 30 days
adverse events experienced throughout the study period in both treatment groups.
The incidence of hepatic encephalopathy episodes, bacterial infections, gastrointestinal bleeding, myocardial infarction, arrhythmia, circulatory overload and arterial hypertension was assessed at the end of the study. The need for mechanical ventilation and the need for dialysis.
Time frame: within 10 days
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 6 - 12 months
Ran from Aug 2018 to primary completion in Apr 2020, 20 months.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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National Hepatology & Tropical Medicine Research Institute