Effects of BRS and LRS on Postoperative Acute Kidney Injury

NCT04835038 | Unknown Phase 4

• 1 other identifier: ChiCTR2100044465
• Study Type: interventional
• Target: 3,400
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Objective: To evaluate the effect of BRS and LRS infusion on acute renal injury in patients undergoing major abdominal surgery
3. 3.Primary outcome: Incidence of AKI at 28 days postoperative (defined as acute kidney injury, according to Kidgo 2012 definition and classification).
4. 4.Study Design: Randomized, controlled, open-label clinical study.

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Sodium Bicarbonate Ringer's Injection group

EXPERIMENTAL

Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)

Drug: Sodium Bicarbonate Ringer's Injection

Sodium Lactated Ringer's Injection group

ACTIVE COMPARATOR

Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)

Drug: Sodium Lactated Ringer's Injection

Interventions

Sodium Bicarbonate Ringer's Injection DRUG

Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)

Sodium Bicarbonate Ringer's Injection group

Sodium Lactated Ringer's Injection DRUG

Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)

Sodium Lactated Ringer's Injection group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA grade Ⅰ-Ⅲ.
• patients aged between 20 and 70, signed informed consent form, and are willing to participate in the study.
• BMI ≤ 30kg/m2.
• 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).
• NYHA cardiac function grade Ⅰ-Ⅲ.
• the function of liver and kidney is normal before operation.
• the blood coagulation function was normal before operation.
• hemoglobin \> 70g/L.
• sinus rhythm was detected by electrocardiogram and there were no other malignant arrhythmias.

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 27-430030, China

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Shiyong Li

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyong Li

CONTACT

18062154189; shiyongli@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate professor

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)