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Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery

NCT02361736 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2016-03-24

Study results available
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Summary

Hydroxyethyl starch (HES) is commonly used as plasma expander during surgery but may be nephrotoxic as seen in studies in patients with sepsis. The investigators hypothesized that the possible nephrotoxicity of 6% HES 130/0.4 could be revealed by measurements of urinary and plasma neutrophil gelatinase-associated lipocalin and interleukin-18 (IL-18) in old patients with normal renal function during orthopaedic surgery.

Conditions

  • Total Fluid Volume Increased

Interventions

DRUG

Hydroxyethyl Starch

6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery

DRUG

Lactate Ringers

Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery

Sponsors & Collaborators

  • Tianjin Union Medical Center

    collaborator OTHER

  • Tianjin First Central Hospital

    collaborator OTHER

  • Yuanyuan Zhang

    lead OTHER

Principal Investigators

  • Yu Yonghao, M.D.,Ph.D · Tianjin Medical University General Hospital

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-12-31
Completion
2016-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02361736 on ClinicalTrials.gov