Preoperative albumin treatment to prevent kidney injury in young heart surgery patients
The Effect of Preoperative Albumin Administration on Postoperative Acute Kidney Injury in Pediatric Patients With Hypoalbuminemia Undergoing Cardiac Surgery: A Prospective Randomized Clinical Trial
This study tests if giving a protein called albumin to young children with low levels before heart surgery can help prevent kidney problems after the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | N/A to 7 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06710353 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of administering albumin to pediatric patients with low albumin levels before undergoing cardiac surgery. The goal is to determine if this treatment can reduce inflammation and prevent acute kidney injury that may occur after cardiopulmonary bypass. The study focuses on children under 7 years of age who meet specific criteria regarding their serum albumin levels. By comparing outcomes in patients receiving albumin versus those receiving crystalloid solutions, the researchers aim to identify effective preoperative interventions.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 7 years old with hypoalbuminemia scheduled for cardiac surgery involving cardiopulmonary bypass.
Not a fit: Patients with abnormal preoperative creatinine levels, liver dysfunction, diabetes, or a history of dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of acute kidney injury in vulnerable pediatric patients undergoing cardiac surgery.
How similar studies have performed: While the specific approach of using preoperative albumin in this context may be novel, similar studies have shown promise in reducing postoperative complications in other surgical populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients under 7 years of age undergoing cardiac surgery with cardiopulmonary bypass * Preoperative serum albumin level of 4.0 g/dL or lower Exclusion Criteria: * abnormal preoperative creatinine level * history of dialysis * liver dysfunction * diabetes * history of hypersensitivity to albumin * coagulation disorders
Where this trial is running
Seoul, Seoul
- Seoul National University Hospital — Seoul, Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Ji-Hyun Lee
- Email: muslab6@snu.ac.kr
- Phone: 82-2-2072-3661
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.