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A study on addition of Albumin to Circuit used in Heart surgery in children

Effect of Albumin addition to Cardio pulmonary bypass Prime on Outcomes in children undergoing open heart surgery- (EACPO Study) - A Randomized Controlled Trial - EACPO study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017104
Enrollment
80
Registered
2019-01-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: Q209- Congenital malformation of cardiacchambers and connections, unspecified

Interventions

Intervention1: 20% Albumin addition to cardiopulmonary bypass prime: Appropriate size CPB circuit is chosen according to the body weight. CPB is established using roller pump with membrane oxygenator.

Sponsors

Sir Ganga Ram Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >1 day and 2. Children with congenital heart diseases who are undergoing open heart surgery using cardiopulmonary bypass

Exclusion criteria

Exclusion criteria: 1. Children with infections prior to surgery 2. Children with preoperative renal dysfunction 3. Children with past history of allergic reaction to human albumin

Design outcomes

Primary

MeasureTime frame
Post-operative parameters a- Hemodynamic parameters in first 24 hours (hypotension, fluid bolus requirement inotrope requirement, urine output, fluid balance). b- Key laboratory parameters at 24 hours (Hb, platelet count, serum albumin) c- Occurrence of Acute kidney injury (as per AKIN criteria). d- Morbidity parameters â?? Duration of ventilation, duration of ICU stay e- In hospital mortality Timepoint: first 24 hours post operative period

Secondary

MeasureTime frame
Intra CPB (cardio pulmonary bypass) Hemodynamic parameters: a. Duration of hypotension during CPB initiation (Seconds) b. Occurrence of significant hypotension during CPB continuation. Significant hypotension is defined as the events of persistent fall in blood pressure below 5th centile (for age) warranting dosage of vasopressor to the CPB reservoir. c. Number of episodes of significant hypotension during CPB. d. Urine output (ml/kg/hour) on CPB Timepoint: During the surgery

Countries

India

Contacts

Public ContactDr Abdul Rauf

Sir Ganga Ram hospital,

dr.raja_joshi@yahoo.com9811118187

Outcome results

None listed

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