Ringer BicarbonatePhase 4NCT04596956
Safety and Efficacy of Sodium Bicarbonate Ringer Injection
A Phase 4 study testing sodium bicarbonate Ringer injection and Lactated Ringer's solution in people with Ringer Bicarbonate and Elderly Abdominal Surgery, run by Chinese PLA General Hospital.
Trial summary
Objectives 1. To observe whether sodium bicarbonate Ringer injections can reduce the incidence of postoperative complications in elderly patients undergoing abdominal surgery. 2. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ringer Bicarbonate, Elderly Abdominal Surgery, Safety
- What is being tested?
- sodium bicarbonate Ringer injection and Lactated Ringer's solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- (1) Patients need to be over 65 years of age, while there is no restriction on gender.
- (2) Patients are planned to undergo upper abdominal surgery under general anaesthesia, with an expected operation time of >2 h, and the infusion volume is >1000ml.
- (3) The patient agrees to participate in the clinical research and signs the informed consent.
Who cannot join
- (1) Emergency surgery
- (2) Hypermagnesemia (defined as serum Mg2+ >1.25mmol/L)
- (3) Patients who participated in other drug trials in the past 6 months
- (4) Known allergic reactions to the test drug and/or its components
- (5) Patients judged to lack the ability of providing informed consent
- (6) Other situations considered unsuitable for enrollment by the researcher.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter Randomized Controlled Trial on the Safety and Efficacy of Sodium Bicarbonate Ringer Injection in Elderly Patients Undergoing Abdominal Surgery
Objectives
- To observe whether sodium bicarbonate Ringer injections can reduce the incidence of postoperative complications in elderly patients undergoing abdominal surgery.
- To observe the effects of sodium bicarbonate Ringer injections on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes, in the perioperative period of elderly patients undergoing abdominal surgery.
Read more
Research design：This study adopts a multicenter, prospective, randomized, controlled, pragmatic clinical trials (PCT) research design.
Sample size：5000 cases. Indication：The experimental group is the elderly patients undergoing abdominal surgery who were administered sodium bicarbonate Ringer injections intraoperatively; the control group is the elderly patients with abdominal surgery who were administered lactated Ringer's injections intraoperatively.
Observational index
Preoperative baseline data collection:
General patient information: basic information (age, height, and weight), preoperative diagnosis, past history, auxiliary examination results, etc.
Intraoperative data collection:
Perioperative vital signs information and arterial blood gas analysis results; The surgical method, operation time, and anaesthesia time; Intraoperative fluid management: The total amount of intraoperative fluids, blood transfusion volume, bleeding volume, urine volume, types and dosage of vasoactive drugs, diuretic dosage, sodium bicarbonate dosage.
Postoperative index:
Postoperative blood biochemical examination: liver function, renal function (urea nitrogen, creatinine), osmotic pressure, lactic acid, and blood sugar levels; Postoperative complications and treatment status Postoperative recovery: postoperative outcome, length of hospital stay, admission to ICU (duration of stay), postoperative eating time, out of bed activity time, gastrointestinal recovery time (exhaust), time for removal of various tubes (gastric tube, urinary tube, and drainage tube), etc.
The observation cut-off point is the patient's discharge. If the patient is still hospitalized 30 days after the operation, the observation will be terminated.
Research process
- Elderly abdominal surgery patients who meet the inclusion criteria will be enrolled and randomly divided into two groups according to the intraoperative application of extracellular fluid supplements. The experimental group is sodium bicarbonate Ringer injection group, and the control group is sodium lactate Ringer injection. Basic preoperative information of patients will be collected. The vital signs, fluid treatment, and surgical anaesthesia will be recorded during the operation, while the recovery and postoperative complications will be recorded during postoperative visits.
- The ability of sodium bicarbonate Ringer injections to reduce postoperative complications in elderly patients undergoing abdominal surgery will be observed.
- The effects of sodium bicarbonate Ringer injection on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes in elderly patients undergoing abdominal surgery will be observed and compared.
- The safety and efficacy of sodium bicarbonate Ringer injection in elderly patients with abdominal diseases will be comprehensively assessed.
- Conditions
- Ringer Bicarbonate, Elderly Abdominal Surgery, Safety, Effectiveness
- Being tested
- sodium bicarbonate Ringer injection, Lactated Ringer's solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium bicarbonate Ringer injectionDrug
Used in surgery
Lactated Ringer's solutionDrug
Used in surgery
| Study group | Role | What they receive |
|---|---|---|
| sodium bicarbonate Ringer injection | Experimental | Not described Receives: Drug: sodium bicarbonate Ringer injection |
| Ringer lactate solution | Active comparator | Not described Receives: Drug: Lactated Ringer's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication rate (including death)
Complications include: bleeding, infection (incision infection, blood infection, urinary system infection), gastrointestinal complications (postoperative intestinal obstruction, anastomotic leakage), pulmonary complications (pulmonary infection, pulmonary embolism) ), cardiovascular complications (cardiac arrest, arrhythmia, heart failure, myocardial infarction), neurological complications (delirium, stroke), urinary system complications (renal insufficiency), etc. (refer to International Surgical Prognosis Study, ISOS ), and died during hospitalization.
Measured: 30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ringer BicarbonateStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596956
- Sponsor's protocol ID
- 2020MZ01
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Randomized Controlled Trial on the Safety and Efficacy of Sodium Bicarbonate Ringer Injection in Elderly Patients Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04596956
- Acronym / sponsor ID
- 2020MZ01
- Conditions
- Ringer Bicarbonate, Elderly Abdominal Surgery, Safety, Effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Oct 2020 (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.
Objectives
- To observe whether sodium bicarbonate Ringer injections can reduce the incidence of postoperative complications in elderly patients undergoing abdominal surgery.
- To observe the effects of sodium bicarbonate Ringer injections on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes, in the perioperative period of elderly patients undergoing abdominal surgery.
Research design：This study adopts a multicenter, prospective, randomized, controlled, pragmatic clinical trials (PCT) research design.
Sample size：5000 cases. Indication：The experimental group is the elderly patients undergoing abdominal surgery who were administered sodium bicarbonate Ringer injections intraoperatively; the control group is the elderly patients with abdominal surgery who were administered lactated Ringer's injections intraoperatively.
Observational index
Preoperative baseline data collection:
General patient information: basic information (age, height, and weight), preoperative diagnosis, past history, auxiliary examination results, etc.
Intraoperative data collection:
Perioperative vital signs information and arterial blood gas analysis results; The surgical method, operation time, and anaesthesia time; Intraoperative fluid management: The total amount of intraoperative fluids, blood transfusion volume, bleeding volume, urine volume, types and dosage of vasoactive drugs, diuretic dosage, sodium bicarbonate dosage.
Postoperative index:
Postoperative blood biochemical examination: liver function, renal function (urea nitrogen, creatinine), osmotic pressure, lactic acid, and blood sugar levels; Postoperative complications and treatment status Postoperative recovery: postoperative outcome, length of hospital stay, admission to ICU (duration of stay), postoperative eating time, out of bed activity time, gastrointestinal recovery time (exhaust), time for removal of various tubes (gastric tube, urinary tube, and drainage tube), etc.
The observation cut-off point is the patient's discharge. If the patient is still hospitalized 30 days after the operation, the observation will be terminated.
Research process
- Elderly abdominal surgery patients who meet the inclusion criteria will be enrolled and randomly divided into two groups according to the intraoperative application of extracellular fluid supplements. The experimental group is sodium bicarbonate Ringer injection group, and the control group is sodium lactate Ringer injection. Basic preoperative information of patients will be collected. The vital signs, fluid treatment, and surgical anaesthesia will be recorded during the operation, while the recovery and postoperative complications will be recorded during postoperative visits.
- The ability of sodium bicarbonate Ringer injections to reduce postoperative complications in elderly patients undergoing abdominal surgery will be observed.
- The effects of sodium bicarbonate Ringer injection on the internal environment, such as water, electrolytes, acid-base balance, and other physiological indexes in elderly patients undergoing abdominal surgery will be observed and compared.
- The safety and efficacy of sodium bicarbonate Ringer injection in elderly patients with abdominal diseases will be comprehensively assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium bicarbonate Ringer injection | Experimental | Drug: sodium bicarbonate Ringer injection |
| Ringer lactate solution | Active comparator | Drug: Lactated Ringer's solution |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- (1) Patients need to be over 65 years of age, while there is no restriction on gender.
- (2) Patients are planned to undergo upper abdominal surgery under general anaesthesia, with an expected operation time of >2 h, and the infusion volume is >1000ml.
- (3) The patient agrees to participate in the clinical research and signs the informed consent.
Key exclusion criteria (6 listed)
- (1) Emergency surgery
- (2) Hypermagnesemia (defined as serum Mg2+ >1.25mmol/L)
- (3) Patients who participated in other drug trials in the past 6 months
- (4) Known allergic reactions to the test drug and/or its components
- (5) Patients judged to lack the ability of providing informed consent
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 injectionUsed in surgery | Drug | sodium bicarbonate Ringer injection |
| Lactated Ringer's solutionUsed in surgery | Drug | Ringer lactate solution |
Primary outcome
Complication rate (including death)
Time frame: 30days
Complications include: bleeding, infection (incision infection, blood infection, urinary system infection), gastrointestinal complications (postoperative intestinal obstruction, anastomotic leakage), pulmonary complications (pulmonary infection, pulmonary embolism) ), cardiovascular complications (cardiac arrest, arrhythmia, heart failure, myocardial infarction), neurological complications (delirium, stroke), urinary system complications (renal insufficiency), etc. (refer to International Surgical Prognosis Study, ISOS ), and died during hospitalization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing sodium bicarbonate Ringer injection and Lactated Ringer's solution in people with Ringer Bicarbonate and Elderly Abdominal Surgery, run by Chinese PLA General Hospital.
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 3 inclusion and 6 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 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 Wenzhu Shi (+86-15110199887, shiwenzhu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (including death) (time frame: 30days). 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 22 Oct 2020; AzTrials last refreshed its copy on 7 Nov 2026.