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Clinical Trial on Safety, Tolerability and Absorption Rules of Intraperitoneal Fluid Infusion in Healthy Volunteers

Clinical Trial on Safety, Tolerability and Absorption Rules of Intraperitoneal Fluid Infusion in Healthy Volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125442
Enrollment
Unknown
Registered
2026-05-27
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

None

Interventions

Experimental Group 1: Intraperitoneal infusion of 1000 mL Lactated Ringer's Injection
Experimental Group 2:Intraperitoneal infusion of 1000 mL Sterile Water for Injection

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-30 years, male; 2. BMI between 18.5-23.9, with weight fluctuation not exceeding 5% in the past month; 3. Physical examination, blood routine, liver and kidney function, electrolytes, coagulation function, electrocardiogram, and abdominal ultrasound confirm good health with no underlying diseases (such as cardiovascular diseases, liver diseases, kidney diseases, digestive system diseases, coagulation disorders, etc.); 4. No history of abdominal surgery, abdominal adhesions, or abdominal infections; 5. No skin infection or damage at the puncture site; 6. No participation in other clinical trials in the past 3 months, and no use of drugs affecting water or electrolyte metabolism; 7. Voluntarily participate in this study, able to understand the study process, cooperate with puncture, testing, and follow-up, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Aged under 18 years or over 30 years. 2. Body weight fluctuated by more than 5% within the past month; BMI below 18.5 or above 23.9. 3. With underlying diseases involving the heart, liver, kidneys, lungs, haematological system, or a history of chronic diseases such as hypertension, diabetes mellitus and thyroid dysfunction. 4. History of abdominal surgery, abdominal adhesion, abdominal infection, intestinal obstruction, ascites or other abdominal disorders. 5. Abnormal coagulation function, bleeding tendency, or current use of anticoagulant drugs (e.g., aspirin, clopidogrel). 6. Skin infection, damage, scar or dermatosis at the puncture site; allergy to balanced salt solution or local anaesthetics (lidocaine). 7. Participation in other clinical trials within the past 3 months, or use of drugs affecting water and electrolyte metabolism. 8. Female gender. 9. Suffering from mental illness or cognitive impairment and unable to cooperate with study procedures and follow-up visits. 10.Other conditions deemed inappropriate for participation in this study by the investigator.

Design outcomes

Primary

MeasureTime frame
Vital signs;Organ function;Coagulation function;Infection indicators;Blood gas analysis;Subjective tolerance;Puncture site assessment;Organ structure assessment;Absorption rate assessment;

Countries

China

Contacts

Public ContactShen Chuanan

Chinese PLA General Hospital

shenchuanan@301hospital.com.cn+86 10 6686 7850

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026