Effect of Anti-histamine in Prevention Systolic Hypotension After Protamine

Protamine Adverse Reaction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583567
• Other study ID #: Si 2018
• Status: Completed
• Phase: Phase 4
• Start date: September 5, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Protamine Adverse Reaction

Intervention

Drug:
• Chlorpheniramine and ranitidine
Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.
• 0.9% Normal Saline
Patient will receive normal saline as placebo.

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Systolic and diastolic blood pressure will be recorded every minutes since the start of protamine infusion (in 7 minutes) til 30 minutes after infusion.	37 minutes
Secondary	Serum tryptase	Serum tryptase will be measured before the administration of protamine and at 30 minutes and 60 minutes after protamine	60 minutes