Using high doses of dexamethasone to prevent kidney injury after heart surgery
The Effect of High Single Dose of Dexamethasone in Prevention of Post-operative Acute Kidney Injury in Cardiac Surgeries Requiring Cardiopulmonary Bypass
PHASE1 · Ain Shams University · NCT06783634
This study tests if giving a single high dose of dexamethasone during heart surgery can help prevent kidney problems in patients after the operation.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 65 Years |
| Sex | All |
| Sponsor | Ain Shams University (other) |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06783634 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a single high dose of dexamethasone (1 mg/kg) in reducing the incidence of post-operative acute kidney injury in patients undergoing elective cardiac surgeries that require cardiopulmonary bypass. Participants will be randomly assigned to receive either dexamethasone or a placebo (normal saline) during their surgery. Comprehensive preoperative assessments will be conducted to ensure patient safety and eligibility. The study aims to determine if dexamethasone can significantly lower the risk of kidney complications following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-65 scheduled for elective cardiac surgery requiring cardiopulmonary bypass with an ASA score of III-IV.
Not a fit: Patients with a history of acute kidney injury, diabetes, or those undergoing urgent or off-pump surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of acute kidney injury in patients undergoing cardiac surgery, improving recovery outcomes.
How similar studies have performed: While the use of dexamethasone in this context is being explored, similar studies have shown promise in reducing complications, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 30-65 years. 2. Sex: Both sex. 3. Patients with American Society of Anesthesiologists (ASA) score III - IV. 4. Patients who were scheduled for any type of elective cardiac surgical procedure requiring cardiopulmonary bypass Exclusion Criteria: 1. Declining to give written informed consent. 2. History of allergy to the medications used in the study. 3. Emergent or planned off-pump procedure 4. Diabetic patients. 5. Patients with recent history of AKI, or have any renal deterioration as GFR \< 80 ml/min./1.73/m2 6. Patients scheduled for urgent cardiac surgery. 7. Patients scheduled for ascending aortic surgery inducing deep hypothermic total circulatory arrest. 8. Patients on high doses of inotropes and/or vasopressors. 9. Patients with high drain(s) in the first 6 hours postoperatively.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (RECRUITING)
Study contacts
- Principal investigator: Nourhan E Abdellatif, MBBCH — Anesthesia resident Ain Shams University
- Study coordinator: nourhan E Abdellatif, MBBCH
- Email: noura.elsawy961@gmail.com
- Phone: +01145544757
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.
Conditions: Acute Kidney Injury After Adult Cardiac Surgery