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Comparative analysis of two solutions for miocardial protection in the correction of congenital cardiopathies.

Comparative analysis of myocardial protection with HTK solution and hypothermic hyperkalemic blood solution in the correction of acyanogenic congenital cardiopathies – a randomized study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9wqbx9
Enrollment
Unknown
Registered
2018-07-26
Start date
2012-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children with acyanogenic congenital heart defects operated for total correction

Interventions

The children were randomized into two groups of 25 patients: Group A - 25 patients. Solution for myocardial protection: Histidine-Tryptophan-Ketoglutarate (HTK), frozen (about 5 ° C), given as a si
2. Serum dosage of cardiac enzymes: troponin and creatine kinase-MB / CK-MB (collected preoperatively at the end of surgery and 6, 12, 18, 24 and 48 hours after surgery)
3. Calculation of the inotropic score (VIS) by type and amount of vasoactive drugs used every two hours, in the first 36 hours after surgery. Group B - 25 patients. Solution for myocardial protectio
3. Calculation of the inotropic score (VIS) by type and amount of vasoactive drugs used every two hours, in the first 36 hours after surgery.
Drug
Procedure/surgery
Other
C14.280

Sponsors

Hospital do Coração de Messejana Dr. Carlos Alberto Studart Gomes
Lead Sponsor
Hospital do Coração de Messejana Dr. Carlos Alberto Studart Gomes
Collaborator

Eligibility

Age
1 Days to 215 Months

Inclusion criteria

Inclusion criteria: Children with acyanotic congenital cardiopathies submitted to corrective surgery with extracorporeal circulation and aortic clamping and volunteers to participate in the study.

Exclusion criteria

Exclusion criteria: Children operated for correction of atrial septal defect exclusively, reoperations, palliative surgeries, emergency surgeries, negative in participation in the study.

Design outcomes

Primary

MeasureTime frame
Expected outcome - Homogeneity between the two groups After analysis of the sample amplitude distribution, mean and standard deviation (SD)of age, weight and time of CPB, surgery and aortic clamping, according to the groups, no statistical difference was evidenced for any of these variables.;Expected outcome - Similar behavior over time of analyzed variables between Groups; Method - Comparative analysis of the estimated marginal means; Regarding the behavior of the troponin, CK-MB, VIS and ETT variables, all of them varied significantly in time (all p <0.001) but with no difference between the solutions, that is, between Groups. Troponin curve between groups - p = 0.997 CK-MB curve between groups - p = 0.693 VIS curve between groups - p = 0.449 Shortening curve VE - p = 0.319

Secondary

MeasureTime frame
A total of 6 (12.0%) patients required cardiopulmonary defibrillation / cardioversion after ECC (p = 0.384), 01 (2.0%) required ECPD (p = 0.312) and 01 (2.0%) to death (p = 0.312). There was no statistical difference between groups for any of these variables.

Countries

Brazil

Contacts

Public ContactAcrisio Valente

Hospital do Coração de Messejana Dr. Carlos Alberto Studart Gomes

acrisiovalente@yahoo.com+558532410990

Outcome results

None listed

Source: REBEC (via WHO ICTRP)