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The effect of using mannitol serum in Cardiopulmonary Bypass Priming on Laboratory Parameters and Delirium in patients undergoing Coronary Artery Bypass graft surgery

The effect of using mannitol serum in Cardiopulmonary Bypass Priming on Laboratory Parameters and Delirium in patients undergoing Coronary Artery Bypass graft surgery

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20221129056660N1
Enrollment
90
Registered
2022-12-04
Start date
2022-12-22
Completion date
Unknown
Last updated
2023-02-07

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

Conditions

Complications caused by the use of cardiopulmonary bypass in patients undergoing coronary bypass surgery. Atherosclerotic heart disease of native coronary artery

Interventions

Intervention 1: Intervention group: adding 200 cc of 20% mannitol serum manufactured by Shahid Ghazi Pharmaceutical Company of Tabriz to Prime solution once in the intervention group. Intervention 2:

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age between 18-70 years old Absence of liver failure in the form of (AST) > 40 unit/L and (ALT) > 40 unit/L No history of heart surgery Absence of serum creatinine above 1.5 mg/dL and patients who had acute kidney failure during the last 5 days due to receiving medication before surgery. Absence of severe carotid stenosis in both carotids or one of the carotids No emergency surgery Absence of infective endocarditis Absence of left ventricular ejection fraction less than 30% and patients with severe right ventricular failure Lack of hemoglobin level less than 10 Lack of body mass index more than 40 Absence of malignant and benign blood cancers Failure to test impaired pulmonary function before surgery, FEV1 <65% No history of mental illness Median sternotomy patients undergoing routine CABG Absence of arrhythmia before operation

Exclusion criteria

Exclusion criteria: Use of hemofilter Retrograde autologous prime before starting cardiopulmonary bypass Receiving Ringer's serum more than 1000 ml during cardiopulmonary bypass Receiving starch serum during and after the operation Using Bertschneider's cardioplegia to induce cardiac arrest ????? ?? ??? ??? Instability of vital signs during surgery Performing additional surgery such as heart valve surgery during CABG surgery Use of ECMO and intra-aortic balloon pump before and after surgery Aortic clamp more than 120 minutes and pump time more than 150 minutes Use of non-invasive mechanical ventilation after surgery Redo-surgery Electrolyte imbalance

Design outcomes

Primary

MeasureTime frame
The average score of cardiac enzymes (CPK, CK-MB, Troponin C). Timepoint: 30 minutes, 24 and 48 hours after surgery. Method of measurement: Venous blood sample, center laboratory.;Average of creatinine and BUN. Timepoint: 30 minutes, 24 and 48 hours after surgery. Method of measurement: Venous blood sample, center laboratory.;Duration of mechanical ventilation, intensive care unit and hospital stay. Timepoint: Until discharge. Method of measurement: Based on hours and days.;Amount of diuresis. Timepoint: During, 24 and 48 hours after surgery. Method of measurement: milliliter.;In-hospital mortality rate. Timepoint: During discharge or death. Method of measurement: Patient's medical record.;The incidence of delirium. Timepoint: Every shift in the intensive care unit. Method of measurement: Delirium Observation Screening Scale(DOSS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Faravan

Oroumia University of Medical Sciences

amir.faravan1991@gmail.com+98 44 3275 4961

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026