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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

Brief Summary:
compare the efficacy of each drug; norepinephrine versus midodrine &octreotide on renal function & survival in patients with HRS.

Condition or disease Intervention/treatment Phase
Renal Impairment in Hepatorenal Syndrome Drug: norepinephrine versus midodrine & octreotide Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pros & Cons of Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1 in Intensive Care Unit.
Actual Study Start Date : August 15, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 15, 2018


Arm Intervention/treatment
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.
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.

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
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.




Primary Outcome Measures :
  1. Reversal of of HRS; serum creatinine value [ Time Frame: within10-14 days ]
    notice the improvement of serum creatinine value with treatment

  2. reversal of hepatorenal syndrome; urine volume [ Time Frame: within 10-14 days ]
    notice the improvement of daily urine volume with treatment


Secondary Outcome Measures :
  1. 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

  2. Economic cost of each method [ Time Frame: within 10-14 days ]
    calculate the economic cost of each arm of treatment in the study

  3. ICU stay [ Time Frame: average 5-21 days ]
    Duration of ICU stay

  4. Hospital stay [ Time Frame: average 5-28days ]
    Duration of hospital stay

  5. 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

  6. Survival [ Time Frame: 30 day survival ]
    post HRS



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455322


Contacts
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Contact: Eman El-Desoki, Ph D 01227409501 eman18350@gmail.com

Locations
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Egypt
NHTMRI Recruiting
Cairo, Egypt
Contact: Eman El-Desoki, Ph D    01227409501    eman18350@gmail.com   
Sponsors and Collaborators
National Hepatology & Tropical Medicine Research Institute

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Responsible Party: Eman Desoki, Consultant of Intensive care medicine, Ph D, National Hepatology & Tropical Medicine Research Institute
ClinicalTrials.gov Identifier: NCT03455322    
Other Study ID Numbers: NHTMRI-2
First Posted: March 6, 2018    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 6 - 12 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatorenal Syndrome
Renal Insufficiency
Syndrome
Disease
Pathologic Processes
Kidney Diseases
Urologic Diseases
Liver Diseases
Digestive System Diseases
Octreotide
Norepinephrine
Midodrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Adrenergic alpha-1 Receptor Agonists