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Safety of renal function in Chinese patients receiving 6% volume therapy with Wanheng during perioperative period: prospective, parallel and open control study

Safety of renal function in Chinese patients receiving 6% volume therapy with Wanheng during perioperative period: prospective, parallel and open control study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041203
Enrollment
Unknown
Registered
2020-12-22
Start date
2020-12-28
Completion date
Unknown
Last updated
2021-03-01

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

Conditions

Surgical patients

Interventions

Experimental group:Intravenous infusion of 6% HES 130/0.4
Control group:Intravenous infusion of sodium acetate Ringer injection

Sponsors

The Frist Affiliated Hospital of the air force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Undergo elective endoscopic gastrointestinal surgery. 2. ASA I-II. 3. Aged 18 years. 4. A written informed consent has been provided. 5. Chinese population. 6. In accordance with the requirements of the approved label, receive 6% Wanheng and / or sodium acetate Ringer injection on the basis of normal clinical practice.

Exclusion criteria

Exclusion criteria: Exclusion criteria. 1. Participated in other studies in the past 3 months. 2. Pregnant and / or lactating women. 3. Body mass index ((BMI)) >= 30. 4. Intracranial or cerebral hemorrhage, renal insufficiency (male SCr > 140 umol / L, female SCr > 120 umol / L and / or oliguria / anuria) or renal replacement therapy (e.g. dialysis), severe liver function injury (ALT and / or AST exceeding 2 times the normal limit), congestive heart failure, pulmonary edema. 5. Serious disorders of internal environment, such as hypernatremia or hyperchloremia, hyperkalemia or severe alkalosis, etc. 6. Critically ill patients, including patients with sepsis. 7. Liquid overload. 8. Dehydration. 9. Bleeding and coagulation disorders or hemorrhagic diseases. 10. Organ transplant patients. 11. Burns. 12. Hypoalbuminemia (serum albumin < 35g/L). 13. Suffering from mental illness. 14. Patients who are known to be allergic to any ingredient of 6% Wanheng ?or Sodium Acetate Ringer injection and / or have any contraindications to Sodium Acetate Ringer injection.

Design outcomes

Primary

MeasureTime frame
Serum creatinine;

Countries

China

Contacts

Public ContactXiong Lize

The First Affiliated Hospital of Air Force Military Medical University

niehuang@163.com+86 13609283068

Outcome results

None listed

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