Comparison of plasma volume, extracellular water and body weight following restricted or standard intraoperative fluid management in patients undergoing elective gastrointestinal surgery

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002683

Enrollment

Registered

2018-02-09

Start date

2018-01-01

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Procedure/Surgery : Patients are randomly allocated into 2 groups (standard intraoperative fluid management group or restrictive intraoperative fluid management group). During intraoperative period, t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective colorectal or stomach surgery under open laparotomy 2. Age = 19 years 3. American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion criteria

Exclusion criteria: 1. Laparoscopic surgery 2. Arrhythmia (except sinus bradycardia and tachycardia) 3. Ischemic heart disease 4. Chronic obstructive pulmonary disease (COPD) 5. Ascites determined by abdominal computed tomography 6. Pretibial pitting edema 7. Hypoalbuminemia (< 2.5 g/dL) or hypoproteinemia (< 5.5 g/dL) 8. Estimated glomerular filtration rate < 60 ml/min 9. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) > 100 IU/L 10. Blood urea nitrogen (BUN) > 30 mg/dl 11. Serum creatinine > 2.0 mg/dl 12. Prothrombin time (PT) > 1.5 international normalized ratio (INR) 13. Activated partial thromboplastin time (aPTT) > 40 sec 14. Hemoglobin < 10 g/dl 15. Hematocrit < 30% 16. Platelet count < 100 × 103 /µL 17. Body weight < 40 or > 100 kg 18. Systemic exposure to indocyanine green (ICG) within 24 h prior to surgery 19. History of allergy to iodides

Design outcomes

Primary

Measure	Time frame
plasma volume	—

Secondary

Measure	Time frame
Intraoperative net fluid;Hemodynamic variables;Extracellular water volume;Body weight	—

Countries

Korea, Republic of

Contacts

Public ContactYong Hun Lee

Asan Medical Center

yhlee0314@gmail.com+82-2-3010-3879

Outcome results