Siriraj Hospital
Bangkok, 10700, Thailand
NCT Number: NCT03583567
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Bangkok, 10700, Thailand
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.
Patient will receive normal saline as placebo.
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.
Time frame: 60 minutes
Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine
Mahidol University
Other
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
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