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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
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.
NHTMRI
Cairo, Egypt
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
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