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Objectives
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sodium bicarbonate Ringer injection | Experimental |
| |
| Ringer lactate solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium bicarbonate Ringer injection | Drug | Used in surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenzhu Shi | Contact | +86-15110199887 | shiwenzhu@163.com |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Lactated Ringer's solution |
| Drug |
Used in surgery |
|