To compare and evaluate the effect of mild versus moderate haemodilution during cardiopulmonary bypass on the neurological complications in patients undergoing heart valve replacement surgery.

Effect of mild versus moderate haemodilution on neuro cognitive outcomes in adult patients undergoing heart valve replacement surgery using cardiopulmonary bypass : A randomized interventional study in Department of Anaesthesia, S.M.S Medical College, Jaipur. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/057179

Enrollment

310

Registered

2023-09-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-09-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Hemodiluton: Hematocrit is maintained more than 25% in one group and 21-25% in the other group intraoperatively while the patient is on cardiopulmonary bypass. Control Intervention1: Ne

Eligibility

Inclusion criteria

Inclusion criteria: Informed written consent. Patients with valvular surgery. Aged between 30 and 60 years.

Exclusion criteria

Exclusion criteria: Previous neurological disease. Congestive heart failure. Diabetes, Hypertension. Acute Myocardial Infarction. Atrial fibrillation or obstructive cardiomyopathy. Renal or Hepatic Impairment. HCT < 21%

Design outcomes

Primary

Measure	Time frame
Neurological Complications Cerebral oximetry values.Timepoint: On post op day 2,4, 6. During Surgery 15 & 30 minutes after initiation of Cardiopulmonary bypass and 5 minutes before weaning of cardiopulmonary bypass.	—

Secondary

Measure	Time frame
Hemodynamic Variables PR, MAP, CVP, SpO2.Timepoint: Baseline, 15 minutes after intubation, before cardiopulmonary bypass, 30 minutes after cardiopulmonary bypass, at ICU admission, 6hours, 12hours & 24 hours after ICU admission.	—

Countries

India

Contacts

Public ContactDr Rasha M

S.M.S Medical College and Attached Hospitals

reemadr.rn@gmail.com9413237117

Outcome results

None listed

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