Comparison effect of plasmalite A and lactate ringer in prime solution on acid and base status and electrolytes)Na.K.Ca)and lactate level and blood sugure in people with Diabet undergoing cardiac surgery with cardiopulmonary bypass at Rajaei Cardiovascular Center

Comparison effect of plasmalite A and lactate ringer in prime solution on acid and base status and electrolytes)Na.K.Ca)and lactate level and blood sugure in people with Diabet undergoing cardiac surgery with cardiopulmonary bypass

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211031052921N1

Enrollment

Registered

2022-12-19

Start date

2022-12-11

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

diabet. Type 2 diabetes mellitus

Interventions

Intervention 1: The intervention group includes people receiving plasmolyte serum, which is prepared by Saman Mashhad company and is used for the prime of the cardiopulmonary bypass device of the pati

Eligibility

Sex/Gender

All

Age

17 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 17 years Elective surgeries The first time of heart surgery (CABG) and valvular surgery LVEF>30% Being diabetic

Exclusion criteria

Exclusion criteria: Creatinine higher than 1.5 Returning to the cardiopulmonary pump for any reason up to 24 hours after the operation Cardiopulmonary arrest during surgery and cardiopulmonary resuscitation Back to the operating room on the first day of surgery

Design outcomes

Primary

Measure	Time frame
Electrolytes (sodium, potassium, calcium) in the blood. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels are considered. Method of measurement: The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form.;Blood lactate level. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar le. Method of measurement: The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form.;Blood sugar. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels. Method of measurement: The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form.;Acid and base conditions. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels. Method of measurement: The validity of this tool is checked by the content validity method, which means that t	—

Measure

Time frame

Electrolytes (sodium, potassium, calcium) in the blood. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels are considered. Method of measurement: The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form.;Blood lactate level. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar le. Method of measurement: The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form.;Blood sugar. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels. Method of measurement: The validity of this tool is checked by the content validity method, which means that the supervisors and advisors will confirm its scientific validity by checking the form.;Acid and base conditions. Timepoint: Arterial blood sample before the start of CPB, after the start of CPB, then every hour until the end of the procedure and then upon entering the ICU and then at 6, 12, 18 and 24 hours for analysis in the electrolyte and balance table. Acid and base, lactate and blood sugar levels. Method of measurement: The validity of this tool is checked by the content validity method, which means that t

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Secondary

Measure	Time frame
Blood hemoglobin level. Timepoint: Arterial blood samples are evaluated before the start of CPB, after the start of CPB, then every hour until the end of the procedure, and then upon entering the ICU, and after that at 6, 12, 18, and 24 hours. The blood sample is taken using a Technomedia blood gas analyzer. Method of measurement: Hemoglobin level is also checked using an arterial blood sample which is a blood cell count check.	—

Measure

Time frame

Blood hemoglobin level. Timepoint: Arterial blood samples are evaluated before the start of CPB, after the start of CPB, then every hour until the end of the procedure, and then upon entering the ICU, and after that at 6, 12, 18, and 24 hours. The blood sample is taken using a Technomedia blood gas analyzer. Method of measurement: Hemoglobin level is also checked using an arterial blood sample which is a blood cell count check.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactrasoolazarfarin

Shahid Rajaee Heart and Vascular Hospital's Medical Research Training Center

dastyarkohanmahnaz@gmail.com+98 21 2204 2026

Outcome results

None listed

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