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The effect of hydroxyethyl starch on renal function

The effect of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection (VOLUVEN?) on the perioperative renal function of patients with liver transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004211
Enrollment
Unknown
Registered
2014-01-26
Start date
2014-02-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

liver transplantation

Interventions

albumin group:4% albumin solution
hydroxyethyl starch group:6% hydroxyethyl starch 130/0.4

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Retrospective study in phase I: The liver transplantation had been done from Jun. 2005 to Jun. 2013. Moreover, patients' preoperative renal function was normal and hydroxyethyl starch was used in their intraoperative fluid therapy. Randomized controlled study in phase II: Recruit cases from Feb. 2014 to Jun. 2015. Aim to collect patients who are going to take liver transplantation in these three clinical medical centers. Moreover, their age should range from 18 yrs to 65 yrs and ASA status should below the level of IV and renal function should be normal and hydroxyethyl starch should be used in their intraoperative fluid therapy.

Exclusion criteria

Exclusion criteria: 1. ASA V and above; 2. Preoperative renal insufficiency; 3. Clinical diagnosis of severe hepatitis; 4. Major intraoperative bleeding> 20 ml/kg; 5. Major resuscitation; 6. Second time operation; 7. The anhepatic stage time> 90 min; 8. Using of immunosuppressive agents significantly affect renal function; 9. Severe postoperative infections; 10. Shorter survival (investigating the mortality of 28 days after operation); 11. Cases with renal function tests less than three items (special in retrospective study).

Design outcomes

Primary

MeasureTime frame
blood urea nitrogen;serum creatinine;blood urea;glomerular filtration rate;serum ß-2 microglobulin;serum cystatin C;N-acetyl-ß-D-glycosidase enzymes;urine ß-2 microglobulin;retinol binding protein;urinary albumin;urine a1 microglobulin;—

Secondary

MeasureTime frame
liver function;coagulation function;postoperative complications;the 28-day mortality after surgery;—

Countries

China

Contacts

Public ContactYue Yun

Beijing YouAn Hospital, Capital Medical University

yueyun@hotmail.com+86 10-13701275595

Outcome results

None listed

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