Safety and Efficacy of Sodium Bicarbonate Ringer Injection
Status:
Not yet recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
Objectives
1. To observe whether sodium bicarbonate Ringer injections can reduce the incidence of
postoperative complications in elderly patients undergoing abdominal surgery.
2. 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
1. 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.
2. The ability of sodium bicarbonate Ringer injections to reduce postoperative
complications in elderly patients undergoing abdominal surgery will be observed.
3. 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.
4. The safety and efficacy of sodium bicarbonate Ringer injection in elderly patients with
abdominal diseases will be comprehensively assessed.