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Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03583567
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : September 25, 2018
Information provided by (Responsible Party):
Mahidol University

Brief Summary:

Protamine remains the anticoagulant of choice for cardiopulmonary bypass (CPB). The process of protamine neutralization of heparin came with the side effects sometimes; it can be life threatening or fetal reaction. The adverse cardiopulmonary response of protamine has been observed during entire history of clinical cardiac surgery. The true mechanism reaction is difficult to defined and the complexity of the clinical situation The classification of protamine reaction has been divided in to main 3 types (transient systemic hypotension secondary to rapid administration, anaphylactic and anaphylactoid reaction and catastrophic pulmonary vasoconstriction.

The reaction from pharmacologic histamine release is the most common type of reaction. Protamine was believed to induce hypotension by this mechanism, and it was demonstrated to release histamine by degranulation of isolated mast cells From the hypothesis that the systemic hypotension cause by the released of histamine. The investigators will measure the serum tryptase which is the enzyme that released from degranulation of human mast cell. Comparing the serum tryptase level of the patient at baseline, 30 min and 60 min after protamine was given.

There for the hypothesis of this study is administrating of H1 and H2 blocker helps attenuate the drop in MAP after protamine is given.

Condition or disease Intervention/treatment Phase
Protamine Adverse Reaction Drug: Chlorpheniramine and ranitidine Drug: 0.9% Normal Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: normal saline will be used as placebo in control group
Primary Purpose: Prevention
Official Title: A Randomized Controlled Study Comparing the Prophylactic Effect of histamine1 and Histamine 2 Receptor Blocker in Prevention Systolic Hypotension After Protamine Administration in Cardiac Patient Having Cardiopulmonary Bypass
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Arm Intervention/treatment
Placebo Comparator: 0.9% Normal Saline
Syringe No 1 contain normal saline 1 mL Syringe No 2 contain normal saline 2 mL
Drug: 0.9% Normal Saline
Patient will receive normal saline as placebo.

Experimental: Chlorpheniramine and ranitidine
Syringe No 1 contain chlorpheniramine 10 mg (1 mL) Syringe No 2 contain ranitidine 50 mg (2 mL)
Drug: Chlorpheniramine and ranitidine
Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.

Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 37 minutes ]
    Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion.

Secondary Outcome Measures :
  1. Serum tryptase [ Time Frame: 60 minutes ]
    Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • ASA physical status 1-3
  • Schedule for open heart surgery

Exclusion Criteria:

  • History of allergy to the study drugs or protamine
  • History of previous cardiac surgery or received protamine
  • History of diabetes with insulin therapy

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 identifier (NCT number): NCT03583567

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Contact: sirilak Suksompong, MD 66891534806

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Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompoong, MD   
Sponsors and Collaborators
Mahidol University
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Principal Investigator: Sirilak Suksompong, MD Mahidol University

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Responsible Party: Mahidol University Identifier: NCT03583567     History of Changes
Other Study ID Numbers: Si 2018
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Additional relevant MeSH terms:
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Vascular Diseases
Cardiovascular Diseases
Ranitidine bismuth citrate
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Heparin Antagonists
Dermatologic Agents
Histamine H1 Antagonists
Anti-Allergic Agents