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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03455322
Recruitment Status : Unknown
Verified January 2018 by Eman Desoki, National Hepatology & Tropical Medicine Research Institute.
Recruitment status was:  Recruiting
First Posted : March 6, 2018
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Desoki, National Hepatology & Tropical Medicine Research Institute

Tracking Information
First Submitted Date  ICMJE January 3, 2018
First Posted Date  ICMJE March 6, 2018
Last Update Posted Date March 8, 2018
Actual Study Start Date  ICMJE August 15, 2017
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • Reversal of of HRS; serum creatinine value [ Time Frame: within10-14 days ]
    notice the improvement of serum creatinine value with treatment
  • reversal of hepatorenal syndrome; urine volume [ Time Frame: within 10-14 days ]
    notice the improvement of daily urine volume with treatment
Original Primary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • recovery of HRS, serum creatinine value [ Time Frame: within10-14 days ]
    notice the improvement of serum creatinine value with treatment
  • recovery of hepatorenal syndrome, urine volume [ Time Frame: within 10-14 days ]
    notice the improvement of daily urine volume with treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2018)
  • adverse events in each arm of treatment in the study [ Time Frame: within 10-14 days ]
    notice any adverse events e.g. (hepatic encephalopathy, bacterial infections, gastrointestinal bleeding, myocardial infarction, arrhythmia, circulatory overload, arterial hypertension, need for mechanical ventilation, need for dialysis
  • Economic cost of each method [ Time Frame: within 10-14 days ]
    calculate the economic cost of each arm of treatment in the study
  • ICU stay [ Time Frame: average 5-21 days ]
    Duration of ICU stay
  • Hospital stay [ Time Frame: average 5-28days ]
    Duration of hospital stay
  • Recurrence of hepatorenal syndrome after cessation of the drug [ Time Frame: within 28 days ]
    rising of serum creatinine &/or decrease urine output; oliguria or anuria
  • Survival [ Time Frame: 30 day survival ]
    post HRS
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2018)
  • adverse events in each arm of treatment in the study [ Time Frame: within 10-14 days ]
    notice any adverse events e.g. (hepatic encephalopathy, bacterial infections, gastrointestinal bleeding, myocardial infarction, arrhythmia, circulatory overload, arterial hypertension, need for mechanical ventilation, need for dialysis
  • cost of each method [ Time Frame: within 10-14 days ]
    calculate the economic cost of each arm of treatment in the study
  • ICU stay [ Time Frame: average 5-21 days ]
    Duration of ICU stay
  • Hospital stay [ Time Frame: average 5-28days ]
    Duration of hospital stay
  • Recurrence of hepatorenal syndrome after cessation of the drug [ Time Frame: within 28 days ]
    rising of serum creatinine &/or decrease urine output; oliguria or anuria
  • Survival [ Time Frame: 30 day survival ]
    post HRS
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.
Official Title  ICMJE Pros & Cons of Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1 in Intensive Care Unit.
Brief Summary compare the efficacy of each drug; norepinephrine versus midodrine &octreotide on renal function & survival in patients with HRS.
Detailed Description

Sixty patients will be enrolled in the study & randomly assigned in a 1:1 manner to receive either intravenous infusion (IVi) norepinephrine in an initial dose of 0.05 which can be increased every 30-60min. up to 0.3ug/Kg/min. to achieve mean arterial pressure ≥ 80-100mmHg& will be 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. Both regimens continued for 7-10 days. Patients included in the study, albumin (20%) will be given by dose 1gm/Kg on the first day then 10-20gm/day & to maintain central venous pressure (CVP) 12-16 cmH2O &stopped if CVP) ≥ 16 cmH2O.

All demographic data will be obtained including the patients' age, sex, body mass index (BMI), associated co-morbidities (diabetes mellitus, hypertension), Child-Pugh score & Sequential Organ Failure Assessment (SOFA).

Vital signs including the heart rate, mean arterial pressure (MAP), central venous pressure (CVP),intra-abdominal pressure (IAP), arterial oxygen saturation (SaO2), urine volume & fluid balance will be recorded at admission and then will be followed up daily and recorded as required.

Laboratory investigations including the complete blood profile, prothrombin time, serum bilirubin, serum albumin, serum creatinine, estimated creatinine clearance & serum sodium will be recorded at randomization as a baseline & then will be assessed on day 0, 1, 3, 5, 7,10 &12of the study.Thirty-day survival will be followed by phone calls to the patient or one of his/her first-degree relatives.

Patients will be classified into three groups. Group (A) = responders; when there was a complete response through reduction in serum creatinine below 1.5mg/dl (133umol/L) &/or urine volume ≥ 500ml/day during treatment. Group (B) = partial responders; when there was a reduction in serum creatinine of greater than 50% of the pretreatment value but with an end of treatment value equal to or greater than 1.5mg/dl (133umol/L) &/or urine volume ≥ 100ml/day &< 500ml/day. Group (C) = non-responders; decrease in serum creatinine level of less than 50% compared with the baseline value to a final value higher than 1.5 mg/dL or an increase in serum creatinine compared with the baseline value.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Renal Impairment in Hepatorenal Syndrome
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: norepinephrine
    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.
    Intervention: Drug: norepinephrine versus midodrine & octreotide
  • Active Comparator: 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
    Intervention: Drug: norepinephrine versus midodrine & octreotide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 27, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 15, 2018
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All patients that will be included in the study have cirrhosis as diagnosed by clinical, biochemical, and ultrasound findings, with HRS type 1, the absence of bacterial infections; however, patients with bacterial infections could be included in the study if renal failure persisted after infection resolution by clinical, laboratory indices up to 48 hours.

Exclusion Criteria:

  • Patients will be excluded if there are advanced cardiovascular diseases due to poor prognosis or any extrahepatic disease that could affect the short-term prognosis, the presence of advanced hepatocellular carcinoma or presence of contraindication to norepinephrine as hypotension due to blood volume deficits except emergency measure, mesenteric or peripheral vascular thrombosis unless there is life-saving procedure, profound hypoxia or hypercarbia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03455322
Other Study ID Numbers  ICMJE NHTMRI-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: 6 - 12 months
Responsible Party Eman Desoki, National Hepatology & Tropical Medicine Research Institute
Study Sponsor  ICMJE National Hepatology & Tropical Medicine Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Hepatology & Tropical Medicine Research Institute
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP