Effects of BRS and LRS on Postoperative Acute Kidney Injury
NCT04835038 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3400
Last updated 2023-04-12
Summary
1. Title: Effects of Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection on postoperative acute kidney injury in patients undergoing major abdominal surgery: a randomized, controlled, open-label clinical study
2. Objective: To evaluate the effect of BRS and LRS infusion on acute renal injury in patients undergoing major abdominal surgery
3. Primary outcome: Incidence of AKI at 28 days postoperative (defined as acute kidney injury, according to Kidgo 2012 definition and classification).
4. Study Design: Randomized, controlled, open-label clinical study.
Conditions
Interventions
- DRUG
-
Sodium Bicarbonate Ringer's Injection
Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)
- DRUG
-
Sodium Lactated Ringer's Injection
Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)
Sponsors & Collaborators
-
Tongji Hospital
lead OTHER
Principal Investigators
-
Shiyong Li · Tongji Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2023-06-30
- Completion
- 2023-08-31
Countries
- China
Study Locations
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