Effects of BRS and LRS on Postoperative Acute Kidney Injury (BRS/LRS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Sodium Bicarbonate Ringer's Injection; Drug: Sodium Lactated Ringer's Injection

Detailed Description

1. Subjects: patients who planned to undergo elective major abdominal surgery.
2. Study data collection period: Subjects signed the consent form until 28 days after discharge or died in hospital or withdrew from the study.
3. Number of research centers/sample size: 3400 patients were planned to be included.
4. Study process: Among patients undergoing elective surgery, the researchers will include patients who meet the inclusion criteria for elective major abdominal surgery and agree to participate in the study. The data to be collected in this study will be recorded by the researcher in the eCRF, including:

(1) Data to be collected during the screening period and preoperatively: patients' basic characteristics and demographic data (2) Data to be recorded during and/or after surgery: primary study indicators, secondary indicators, and other indicators.

• Study Type: Interventional
• Enrollment (Anticipated): 3400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shiyong Li; Phone Number: 18062154189; Email: shiyongli@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 27-430030
      • Recruiting
      • Tongji Hospital
      • Contact: Pu Zhou, Phd; Phone Number: 86-27-83663250

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ASA grade Ⅰ-Ⅲ.
2. patients aged between 20 and 70, signed informed consent form, and are willing to participate in the study.
3. BMI ≤ 30kg/m2.
4. elective major abdominal surgery for the first time (radical resection of ovarian cancer, radical resection of cervical cancer, radical resection of gastric cancer, radical resection of colorectal cancer, radical resection of bladder tumor and radical resection of prostate tumor).
5. NYHA cardiac function grade Ⅰ-Ⅲ.
6. the function of liver and kidney is normal before operation.
7. the blood coagulation function was normal before operation.
8. hemoglobin > 70g/L.
9. sinus rhythm was detected by electrocardiogram and there were no other malignant arrhythmias.

Exclusion Criteria:

1. Emergency surgery.
2. liver and kidney surgery.
3. complicated with chronic respiratory diseases and FEV1/FVC < 70%.
4. the operation time is less than 2 hours.
5. patients with mental illness or cognitive impairment.
6. uncontrolled hypertension with blood pressure higher than 180 × 100mmHg.
7. patients with hypothyroidism.
8. pregnant or lactating patients. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sodium Bicarbonate Ringer's Injection group; Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)	Drug: Sodium Bicarbonate Ringer's Injection; Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)
Active Comparator: Sodium Lactated Ringer's Injection group; Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)	Drug: Sodium Lactated Ringer's Injection; Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative acute renal injury	The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012)	28 days after surgery

Collaborators and Investigators

• Sponsor: Tongji Hospital
• Investigators: Principal Investigator: Shiyong Li, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: ChiCTR2100044465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No