N/A N=120 Randomized Triple-blind

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

Total Fluid Volume Increased

Bottom Line

View on ClinicalTrials.gov: NCT02361736 ↗

Enrolled (actual)

120

Serious AEs

0.0%

Results posted

Mar 2016

Primary outcome: Primary: Concentration of NGAL in Urine on 5 Time Point — 5.6; 4.9; 5.2; 5.1 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Hydroxyethyl Starch (Drug); Lactate Ringers (Drug)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: Yuanyuan Zhang
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Concentration of NGAL in Urine on 5 Time Point	5.6; 4.9; 5.2; 5.1; 4.9; 4.9	—
PRIMARY Concentration of IL-18 in Urine on 5 Time Point	86.6; 82.7; 83.2; 89.5; 118.5; 109.6	—
PRIMARY Concentration of IL-18 in Plasma on 5 Time Point	81.0; 79.3; 81.4; 81.0; 83.8; 84.2	—
PRIMARY Concentration of NGAL in Plasma on 5 Time Point.	4.1; 4.0; 4.0; 4.2; 4.4; 4.3	—
SECONDARY Concentration of β2 Microglobulin in Urine	93.2; 96.4; 90.6; 97.1; 99.8; 101.7	—
SECONDARY Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point	61.9; 63.9; 63.5; 63.5; 63.0; 64.0	—
SECONDARY Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point	1.89; 1.96; 1.84; 1.98; 1.90; 1.90	—

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.

Eligibility Criteria

Inclusion Criteria

Old patients scheduled to undergo orthopaedic surgery under a intravertebral anesthesia. (American Society of Anesthesiologists physical status I-Ⅲ)

Exclusion Criteria

Allergy and contraindication to HES
Infections and malignancies
Sepsis
History of heart failure or New York Heart Association(NYHA)>Ⅲ
Renal failure or Cr>108μmol/L，BUN>8.3mmol/L
Undergoing dialytic treatments
Intracranial hemorrhages
Taking non-steroidal antiinflammatory agent for a long time
Inability to understand the Study Information Sheet and provide a written consent to take part in the study

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02361736). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.