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Clinical Trials/NCT01898897
NCT01898897
Unknown
Not Applicable

Combined Anesthesia Considerations in Uro-Genital Robot Assisted Laparoscopic Surgeries: Acute Kidney Injury

Iuliu Hatieganu University of Medicine and Pharmacy1 site in 1 country60 target enrollmentMarch 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia; Reaction
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Enrollment
60
Locations
1
Primary Endpoint
acute kidney injury
Last Updated
12 years ago

Overview

Brief Summary

The study hypothesis is that regional anesthesia offers better outcome for the patients who underwent robot assisted laparoscopic urogenital surgery.

Detailed Description

The study investigates the effect of combined anesthesia on occurrence of acute kidney injury in robot assisted laparoscopic urogenital surgery.Renal function is assessed according to the new RIFLE and AKIN criteria, and by determining serum and urinary neutrophil gelatinase associated lipocalin.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
May 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Responsible Party
Principal Investigator
Principal Investigator

Mihaly Orsolya

MD, PhD

Iuliu Hatieganu University of Medicine and Pharmacy

Eligibility Criteria

Inclusion Criteria

  • signed the informed consent without previous renal function alteration respiratory and hemodynamic stability

Exclusion Criteria

  • refuse to sign the informed consent chronic or and stage renal disease severe systemic diseases

Outcomes

Primary Outcomes

acute kidney injury

Time Frame: 4 days

Acute kidney injury, previously referred as acute renal failure is a serious complication of major surgery. The diagnostic of subclinical alteration of kidney function is possible with the novel biomarkers, such as neutrophil gelatinase associated lipocalin (NGAL). Modified NGAL values can be detected in patients urine and serum at 6 hours from the renal injury. In our study, we assessed the renal function by determining basal creatinine and follow the creatinine values 4 days postoperative. Acute kidney injury (AKI)is defined as a 0.3 mg/ml rise in serum creatinine from baseline, according to the AKIN criteria. NGAL is measured (with ELISA technique) at 6 hours and 12 hours from the induction of the anesthesia. The incidence of AKI will be compared in the different anesthesia techniques for robot assisted urogenital laparoscopic surgery.

Secondary Outcomes

  • postoperative outcome(10 days)

Study Sites (1)

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