Evaluate the Nephrotoxicity by 6% Hydroxyethyl Starch 130/0.4 in Old Patients During Orthopaedic Surgery
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 12, 2015
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
March 24, 2016
CompletedMarch 24, 2016
February 1, 2016
9 months
February 2, 2015
January 25, 2016
February 23, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Concentration of NGAL in Urine on 5 Time Point
Neutrophil gelatinase-associated lipocalin (NGAL) is a small protein, which is filtered via the glomeruli and reabsorbed in the proximal tubules, and thus low concentrations of NGAL can be measured in the blood and urine.
-1d, 0d, 1d, 3d, 5d after surgery
Concentration of IL-18 in Urine on 5 Time Point
IL-18 is mainly created from proximal kidney tubules which is a proinflammatory factor that can be detected in earlier urine of AKI animal models.
-1d, 0d, 1d, 3d, 5d after surgery
Concentration of IL-18 in Plasma on 5 Time Point
-1d, 0d, 1d, 3d, 5d after surgery
Concentration of NGAL in Plasma on 5 Time Point.
concentration of NGAL in plasma on 5 time point. Biomarkers are measured by ELISA.
-1d, 0d, 1d, 3d, 5d after surgery
Secondary Outcomes (3)
Concentration of β2 Microglobulin in Urine
-1d, 0d, 1d, 3d, 5d after surgery
Estimated Glomerular Filtration Rate(eGFR) on 5 Time Point
-1d, 0d, 1d, 3d, 5d after surgery
Ratio of the Urine Trace Albumin and Creatinine(ACR) on 5 Time Point
-1d, 0d, 1d, 3d, 5d after surgery
Study Arms (2)
Lactate Ringers
SHAM COMPARATORLactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Hydroxyethyl Starch
EXPERIMENTAL6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers' is administrated to the patient until the end of the surgery
Interventions
6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery
Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
Eligibility Criteria
You may qualify if:
- Old patients scheduled to undergo orthopaedic surgery under a intravertebral anesthesia. (American Society of Anesthesiologists physical status I-Ⅲ)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yuanyuan Zhanglead
- Tianjin Union Medical Centercollaborator
- Tianjin First Central Hospitalcollaborator
Study Sites (1)
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
Related Publications (1)
Zhang Y, Yu Y, Jia J, Yu W, Xu R, Geng L, Wei Y. Administration of HES in elderly patients undergoing hip arthroplasty under spinal anesthesia is not associated with an increase in renal injury. BMC Anesthesiol. 2017 Feb 21;17(1):29. doi: 10.1186/s12871-017-0320-8.
PMID: 28222674DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
We may have to prolong the follow-up visit for patients.
Results Point of Contact
- Title
- Dr. Yuanyuan Zhang
- Organization
- Tianjin Medical University General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Yonghao, M.D.,Ph.D
Tianjin Medical University General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Tianjin Medical University General Hospital Ethics Committee
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 12, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
March 24, 2016
Results First Posted
March 24, 2016
Record last verified: 2016-02