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Multicenter, single blind clinical study of sodium bicarbonate Ringer's solution as fluid replacement in long-term abdominal open surgery

Multicenter, single blind clinical study of sodium bicarbonate Ringer's solution as fluid replacement in long-term abdominal open surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030634
Enrollment
Unknown
Registered
2020-03-08
Start date
2020-03-16
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open abdominal surgery

Interventions

control group:Give lactate Ringer's solution for rehydration
Experimental group:Give sodium bicarbonate Ringer's solution for rehydration

Sponsors

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years old, who are planning to undergo open abdominal surgery and expected operation time > 3 hours (including open radical gastrectomy, pancreatoduodenectomy, hilar cholangiocarcinoma, radical cholecystectomy, partial hepatectomy, open radical nephrectomy for complex renal cancer, ovarian cancer reduction surgery, thoracoabdominoesophageal cancer resection); 2. With no severe center of gravity, brain and lung organic lesions, no serious liver and kidney dysfunction and endocrine diseases, no history of mental illness, no consciousness disorder; 3. With no hypermagnesemia (serum Mg2 + > 1.25mmol/l was hypermagnesemia); 4. The patients agreed to participate in the clinical study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Body mass index (BMI) 30kg / m2; 2. Serum Mg2 + > 1.25mmol/l; 3. Patients with significant abnormality of liver and kidney function, creatinine 1.5 times higher than the upper limit of normal value or received dialysis treatment within one month before operation, liver function abnormality and child grade > 6 (Grade B or grade C); 4. With serious organic diseases of heart and lung function (such as moderate and severe heart valve disease, cardiac ejection fraction < 55%, various arrhythmias requiring pacemaker, atrial fibrillation, severe lung function damage, etc.); 5. Patients judged to lack the ability of informed consent; 6. Patients who participated in other drug trials in the last 6 months; 7. Patients with known allergic reactions to the investigational product and / or its components; 8. Patients with hypothyroidism; 9. Pregnant or lactating patients; 10. With a known history of alcohol or drug abuse; Otherwise, the clinical responsible doctor or clinical sharing doctor judges the patient as unsuitable.

Design outcomes

Primary

MeasureTime frame
Na+;K+;Cl-;Ca2+;pH;BE;HCO3-;Urine volume;blood pressure;Heart rhythm;sPO2;liver function;renal function;osmotic pressure;lactic acid;blood sugar;Operative duration;Duration of anesthesia;Total intraoperative crystalloid fluid;Total intraoperative colloids;Total bleeding;Total urine output;Postoperative intestinal exhaust time;Extubation time of gastric tube;Extraction time of abdominal drainage tube;Time of getting out of bed after operation;Postoperative eating time;Postoperative hospital stay;Stay time in ICU after operation;ncidence of postoperative bleeding;

Secondary

MeasureTime frame
ncidence of postoperative incision infection;Incidence of postoperative anastomotic leakage;Incidence of postoperative intestinal obstruction;Incidence of postoperative pulmonary infection;Incidence of postoperative arrhythmia;Incidence of postoperative heart failure;Incidence of myocardial infarction after operation;Incidence of postoperative stroke;

Countries

China

Contacts

Public ContactXiaoqing Chai

The First Affiliated Hospital of University of science and technology of China (Anhui Provincial Hospital)

xiaoqingchai@163.om+86 13805518889

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026