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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245502
Other study ID # 1297
Secondary ID
Status Completed
Phase N/A
First received August 8, 2017
Last updated December 14, 2017
Start date August 20, 2017
Est. completion date December 1, 2017

Study information

Verified date December 2017
Source Turkiye Yuksek Ihtisas Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Venoarterial CO2 difference(delta PCO2), lactate, central venous oxygen saturation(ScVO2) will be recorded in several steps in coronary artery bypass graft and valvular cardiac operations. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.


Description:

Preoperative creatinine values, demographic data, comorbidities will be recorded in ASA I-II elective coronary artery and valvular cardiac surgery patients. Intraoperative delta PCO2, lactate, ScVO2 will be recorded in several steps. The patients will be divided into two groups as Transfused, and Non-Transfused Groups observationally. The trend of delta CO2, lactate, ScVO2, postoperative creatinine values, postoperative complications and 28 days mortality will be compared.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date December 1, 2017
Est. primary completion date November 1, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Elective cardiac surgery, stable cardiac function

Exclusion Criteria:

- Clinical signs of heart failure, symptomatic cerebral or peripheral failure, uncontrolled diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood transfusion
The transfusion of erythrocyte suspension

Locations

Country Name City State
Turkey Turkiye Yuksek Ihtisas Education and Research Hospital Ankara

Sponsors (1)

Lead Sponsor Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complication The postoperative neurologic, renal, hepatic, respiratory complications 5 days
Secondary Mortality mortality 28 days
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