Using norepinephrine and fluid therapy to improve kidney transplant outcomes

Norepinephrine Infusion Combined With Goal-directed Fluid Therapy Reduces Delayed Graft Function Incidence in Patients Undergoing Kidney Transplantations: a Randomized Multicenter Clinical Trial

This study is testing if giving norepinephrine along with a special fluid treatment can help kidney transplant patients recover better and avoid complications after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 380 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Locations: 3 sites (Zhengzhou, Henan and 2 other locations)
• Trial ID: NCT06367205 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of norepinephrine infusion combined with goal-directed fluid therapy (GDFT) in reducing the incidence of delayed graft function (DGF) in patients undergoing kidney transplantation. DGF is a common complication that can lead to serious postoperative issues, and this trial aims to optimize perioperative management strategies. By comparing GDFT with regular fluid therapy, the study seeks to provide insights into improving kidney transplant outcomes and patient recovery. Participants will be monitored closely to assess the impact of these interventions on their postoperative health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for cadaveric kidney transplantation under general anesthesia.

Not a fit: Patients who may not benefit include those with severe cardiac or liver dysfunction, respiratory diseases, or those undergoing simultaneous organ transplants.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the occurrence of delayed graft function in kidney transplant recipients, leading to better overall outcomes.

How similar studies have performed: While goal-directed fluid therapy has shown promise in critical care settings, its specific application in kidney transplantation remains under investigation, making this study a potentially novel approach.

Eligibility criteria

Inclusion Criteria:

1. Recipients aged 18 years or older
2. Scheduled to undergo kidney transplantations under general anesthesia
3. Cadaveric kidney transplantations
4. Sign the informed consent form

Exclusion Criteria:

1. Donors aged under 18 years
2. Donor kidneys classified as Maastricht category I or II
3. Contraindications to radial artery catheterization
4. Pregnancy
5. Cardiac dysfunction (exercise tolerance less than 4 METS)
6. Severe liver dysfunction (Child Pugh C-grade)
7. Respiratory diseases with tidal volume intolerance exceeding 8ml/kg
8. Severe arrhythmias, including atrial fibrillation, frequent atrial or ventricular premature beats, moderate or severe aortic and mitral regurgitation
9. Double-kidney transplantations
10. Simultaneous organ or additional surgeries during kidney transplantations
11. Repeat kidney transplantations
12. Concurrent participation in other clinical trials
13. Patients deemed ineligible by researchers

Where this trial is running

Zhengzhou, Henan and 2 other locations

• the First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• General Hospital of Northern Theatre Command — Shenyang, Liaoning, China (Not_yet_recruiting)
• Renji Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Diansan Su, Dr. — Department of Anesthesiology Renji Hospital
• Study coordinator: Diansan Su, Dr.

Conditions Delayed Graft Function; End Stage Renal Disease; Kidney Transplantation; Norepinephrine; Goal-directed fluid therapy; Randomized controlled trial