Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorLourdes Montero Cruces
About this trial
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age.
Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
Disqualifiers
Pregnancy.
Aortic arch procedures.
Procedures in which hypothermia <28ºC is expected during the intervention.
Minimally invasive procedures "Port Access".
Trial design
Design model
Parallel
Treatments tested in this trial
Custodiol Htk Soln
DrugPatients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.
Buckberg Cardi-Braun
DrugPatients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: BuckbergActive comparator 1 intervention
Group B: CustodiolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparison of the composite event
Comparison of the composite event of death, perioperative AMI, low cardiac postoperative output with need for ionotropics, and AKIN-III acute kidney failure
Time frame
90 days after the interventionSecondary outcomes
1
Differences in the incidence of elevation of Troponin
Comparison of the elevation of Troponin I US at 12 and 24 hours after the procedure.
Time frame
90 days after the intervention2
Differences in the 90-day mortality rate
Comparison of 90-day postoperative mortality
Time frame
90 days after the intervention3
Differences in the incidence of low cardiac postoperative output
Comparison of low cardiac postoperative output event with need for ionotropic drugs in the first 24 hours.
Time frame
90 days after the intervention4
Differences in the incidence of acute kidney failure event
Comparison of AKIN-III acute kidney failure event
Time frame
90 days after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lourdes Montero Cruces
Lead sponsor
Hospital San Carlos, Madrid
Sponsor institution
Source ClinicalTrials.gov