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

Primary Purpose

Acute Kidney Injury

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Sodium Bicarbonate Ringer's Injection

Sodium Lactated Ringer's Injection

About this trial

This is an interventional other trial for Acute Kidney Injury

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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. -

Sites / Locations

Tongji hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sodium Bicarbonate Ringer's Injection group

Sodium Lactated Ringer's Injection group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative acute renal injury

The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012)

Secondary Outcome Measures

Full Information

NCT ID

NCT04835038

First Posted

April 6, 2021

Last Updated

April 11, 2023

Sponsor

Tongji Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04835038

Brief Title

Effects of BRS and LRS on Postoperative Acute Kidney Injury

Acronym

BRS/LRS

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Subjects: patients who planned to undergo elective major abdominal surgery. Study data collection period: Subjects signed the consent form until 28 days after discharge or died in hospital or withdrew from the study. Number of research centers/sample size: 3400 patients were planned to be included. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sodium Bicarbonate Ringer's Injection group

Arm Type

Experimental

Arm Description

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

Arm Title

Sodium Lactated Ringer's Injection group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sodium Bicarbonate Ringer's Injection

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sodium Lactated Ringer's Injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative acute renal injury

Description

The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012)

Time Frame

28 days after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Shiyong Li

Phone

18062154189

shiyongli@hust.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shiyong Li

Organizational Affiliation

Tongji Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tongji hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

27-430030

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pu Zhou, Phd

Phone

86-27-83663250

12. IPD Sharing Statement

Plan to Share IPD

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Effects of BRS and LRS on Postoperative Acute Kidney Injury

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