Acute Kidney InjuryPhase 4BRS/LRSNCT04835038
Effects of BRS and LRS on Postoperative Acute Kidney Injury
A Phase 4 study testing Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection in people with Acute Kidney Injury, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- the blood coagulation function was normal before operation.
- hemoglobin > 70g/L.
- sinus rhythm was detected by electrocardiogram and there were no other malignant arrhythmias.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tongji hospital
Wuhan, Hubei, 27-430030
Pu Zhou, Phd, 86-27-83663250
About this study
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
- 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.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Sodium Bicarbonate Ringer's Injection, Sodium Lactated Ringer's Injection
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate Ringer's InjectionDrug
Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)
Sodium Lactated Ringer's InjectionDrug
Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)
| Study group | Role | What they receive |
|---|---|---|
| Sodium Bicarbonate Ringer's Injection group | Experimental | Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection) Receives: 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) Receives: Drug: Sodium Lactated Ringer's Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute renal injury
The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012)
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jun 2021
- Primary completionJun 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shiyong Li, Tongji Hospital
- Investigators
- Shiyong Li, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835038
- Sponsor's protocol ID
- ChiCTR2100044465
- Acronym
- BRS/LRS
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04835038
- Acronym / sponsor ID
- BRS/LRS / ChiCTR2100044465
- Conditions
- Acute Kidney Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,400 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Bicarbonate Ringer's Injection group | Experimental | Drug: Sodium Bicarbonate Ringer's InjectionIntraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection) |
| Sodium Lactated Ringer's Injection group | Active comparator | Drug: Sodium Lactated Ringer's InjectionIntraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Bicarbonate Ringer's InjectionIntraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection) | Drug | Sodium Bicarbonate Ringer's Injection group |
| Sodium Lactated Ringer's InjectionIntraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection) | Drug | Sodium Lactated Ringer's Injection group |
Primary outcome
Postoperative acute renal injury
Time frame: 28 days after surgery
The incidence of AKI at 28 days after surgery (Acute kidney injury is defined and graded according to KIDGO 2012)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyong Li principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium Bicarbonate Ringer's Injection and Sodium Lactated Ringer's Injection in people with Acute Kidney Injury, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiyong Li (18062154189, shiyongli@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute renal injury (time frame: 28 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.