drugset / Trial / NCT03583567

Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

NCT03583567

Phase 4 Completed 40 enrolled Mahidol University
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2018-09-05
Primary completion
2019-03-31
Completion
2019-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorpheniramine Unknown 10 mg Intravenous
Subject Ranitidine Unknown 50 mg Intravenous

Indications