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Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock

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ClinicalTrials.gov Identifier: NCT03433508
Recruitment Status : Not yet recruiting
First Posted : February 14, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

Brief Summary:
Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb <8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.

Condition or disease Intervention/treatment Phase
Cirrhosis Biological: Liberal Other: Restrictive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock: An Open Label Randomized Controlled Trial
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : February 15, 2019
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liberal
2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
Biological: Liberal
2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days

Active Comparator: Restrictive
To maintain the target Hemoglobin of 7 to 8 gm/dL.
Other: Restrictive
To maintain the target Hemoglobin of 7 to 8 gm/dL.




Primary Outcome Measures :
  1. Mortality in both groups [ Time Frame: 28 dyas ]

Secondary Outcome Measures :
  1. Improvement in vasopressors in both groups [ Time Frame: 28 days ]
    Improvement is defined as tapering the dose of vasopressors

  2. Incidence of complications in both groups [ Time Frame: 28 days ]
  3. Length of ICU (Intensive Care Unit) stay [ Time Frame: 28 days ]
  4. Requirement of mechanical ventilation in both groups [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Cirrhosis with septic shock.
  2. Age >18 years

Exclusion Criteria:

  1. Previous severe adverse reaction with blood products,
  2. Disseminated intravascular coagulopathy
  3. HCC
  4. Pregnancy
  5. Malignancy
  6. Active gastrointestinal bleeding
  7. Intracranial bleeding
  8. Chronic Kidney disease with Maintenance Hemodialysis
  9. Pulmonary Edema
  10. Congestive Heart Failure
  11. Lack of informed consent

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): NCT03433508


Contacts
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Contact: Dr Harsh Tevathia, MD 01146300000 hershey4686@gmail.com

Locations
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India
Institute of Liver and Biliary Sciences Not yet recruiting
New Delhi, Delhi, India, 110070
Contact: Harsh Tevethia, MD    7835056137    hershey4686@gmail.com   
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

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Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT03433508     History of Changes
Other Study ID Numbers: ILBS-cirrhosis-01
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Liver Cirrhosis
Shock, Septic
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Shock
Benzocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents