Antihistamine for Prevention of HTR After Blood Primed CPB
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-7
SponsorKasr El Aini Hospital
About this trial
This study will be a randomized, double-blinded, placebo-controlled study conducted at a university hospital. Forty children undergoing elective repair of a congenital heart defect will be included. The patients will be randomly allocated (20 patients per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from CPB, before protamine administration.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Acyanotic congenital heart disease.
Age :1 -7 years.
Genre: both.
Disqualifiers
Redo patient.
History of allergy to antihistamines.
Bleeding disorders with INR > 1.5 and/or platelets < 50,000.
Emergency procedure.
Trial design
Design model
Parallel
Treatments tested in this trial
Antihestamine
Drugchlorpheniramine 0.25 mg/Kg in 2 ml immediately after separation from CPB, before protamine administration
Placebo
Drugequal volume normal saline
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: AntihistamineActive comparator 1 intervention
Group B: controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
hypotention episode incidance
Incidence of hypotension (20% MBP drop \< baseline)15 minutes post-CBP weaning
Time frame
15 min,post cardiopulmonary bypass weaningSponsors and contacts
Click on the lead sponsor to view all of their trials.
Kasr El Aini Hospital
Lead sponsor
Misr University for Science and Technology
Collaborator
Source ClinicalTrials.gov