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The evaluation and comparison of Coronary sinus Inflammatory and ischemic biomarkers level in retrograde-anterograde versus anterograde cardioplegia during cardiopulmonary bypass surgery: A single blinded randomized controlled trial

The evaluation and comparison of Coronary sinus Inflammatory and ischemic biomarkers level in retrograde-anterograde versus anterograde cardioplegia during cardiopulmonary bypass surgery: A single blinded randomized controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201202048860N1
Enrollment
100
Registered
2013-07-16
Start date
2014-02-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Myocardial Infarction. myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset

Interventions

Intervention 1: Control group: cold, Bloody cardioplegic solution (st. Thomas II based) is applied at an initial volume of 1000 mL in all patients. A second or third shot of 300 to 500 mL is given to
Treatment - Surgery
Control group: cold, Bloody cardioplegic solution (st. Thomas II based) is applied at an initial volume of 1000 mL in all patients. A second or third shot of 300 to 500 mL is given to patients with re
Intervention group: the initial dose delivered in the same route and the next cardiolpegia will be infused via retrograde catheter 200-300 ml after every distal anastomosis for CABG cases or 300-500 m

Sponsors

Rajaie cardiovascular medical and research center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: all patients undergoing cardiopulmonary bypass surgery at one operator service in our institution were prospectively screened for inclusion in the investigation. Consecutive patients with the following characteristics were selected for inclusion in the study: valvular with at least two vessels coronary disease. Exclusion criteria: total respiratory disability; renal failure (Cr > 2); age = 80 years old; history of MI in 4 weeks preoperatively; failure to retrograde catheter insertion; where total respiratory disability is any of: height-corrected FEV1 (1.1-1.4) and DLCO less than 30 percent predicted (Technical revisions to medical criteria for determinations of disability).

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mortality. Timepoint: 30-day after surgery. Method of measurement: ID.

Secondary

MeasureTime frame
Blood level of IL18 in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes, and 12 hours after completion of CPB. Method of measurement: Laboratory kit.;Blood level of Na in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of K in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of Ca in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of Lactate in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of Lactate/Pyruvate in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of HSCRP in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of HCO3 in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.;Blood level of PH in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Alireza Alizadeh Ghavidel

Rajaie heart center

aghavidel@rhc.ac.ir+98 21 2392 2147

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026