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.|
|ClinicalTrials.gov Identifier: NCT03583567|
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : September 25, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||normal saline will be used as placebo in control group|
|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|
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.
- 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.
- 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
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): NCT03583567
|Contact: sirilak Suksompong, MDfirstname.lastname@example.org|
|Bangkok, Thailand, 10700|
|Contact: Sirilak Suksompoong, MD email@example.com|
|Principal Investigator:||Sirilak Suksompong, MD||Mahidol University|