Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels

• Sponsor: Antalya Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03607279
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Actual Duration (Months): 7
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the effect of two surgical techniques (open vs robotic assisted) on plasma levels of NGAL (neutrophil gelatinase-associated lipocalin) after radical prostatectomy.

Condition or Disease	Intervention/Treatment	Phase
Prostatectomy	Procedure: NGAL

Detailed Description

Patients undergoing radical prostatectomy are at increased risk of acute kidney injury (AKI) because of intraoperative bleeding, obstructive uropathy and older age. In particular robot-assisted laparoscopic radical prostatectomy (RALP) which is in increasing demand as an alternative surgical option for retropubic radical prostatectomy (RRP) is associated with postoperative renal dysfunction because pneumoperitoneum during RALP can decrease cardiac output and renal perfusion. NGAL may become important for diagnosis of postoperative AKI after urogenital oncosurgery.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 66 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Comparison of Plasma Neutrophil Gelatinase - Associated Lipocalin (NGAL) Levels After Robot-assisted Laparoscopic Versus Retropubic Radical Prostatectomy
• Actual Study Start Date: Jan 1, 2017
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
NGAL - retropubic radical prostatectomy Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia	Procedure: NGAL
NGAL - robotic radical prostatectomy Plasma NGAL was determined at baseline, 6 and 12 hrs after induction of anaesthesia	Procedure: NGAL

Outcome Measures

Primary Outcome Measures

1. Plasma NGAL [0 hours, 6 hours and 12 hours after surgery]

   Plasma NGAL was determined at baseline, 6 hours and 12 hours after surgery, ng/ml

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients who undergo prostatectomy

• American Society of Anesthesiology (ASA) I-III

Exclusion Criteria:

• preexisting renal disease

• emergency surgery

• heart failure

• peripheral vascular disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya		Turkey	07100

Sponsors and Collaborators

• Antalya Training and Research Hospital

Investigators

• Principal Investigator: Arzu Karaveli, Netherlands: Ministry of Health, Welfare and Sports

Study Documents (Full-Text)

None provided.

More Information

Publications

• Joo EY, Moon YJ, Yoon SH, Chin JH, Hwang JH, Kim YK. Comparison of Acute Kidney Injury After Robot-Assisted Laparoscopic Radical Prostatectomy Versus Retropubic Radical Prostatectomy: A Propensity Score Matching Analysis. Medicine (Baltimore). 2016 Feb;95(5):e2650. doi: 10.1097/MD.0000000000002650.
• Orsolya M, Attila-Zoltan M, Gherman V, Zaharie F, Bolboaca S, Chira C, Bodolea C, Tomuleasa C, Irimie A, Coman I, Ionescu D. The effect of anaesthetic management on neutrophil gelatinase associated lipocalin (NGAL) levels after robotic surgical oncology. J BUON. 2015 Jan-Feb;20(1):317-24.

• Responsible Party: Arzu Karaveli, Study director, Antalya Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03607279
• Other Study ID Numbers: 2016-118
• First Posted: Jul 31, 2018
• Last Update Posted: Dec 19, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Arzu Karaveli, Study director, Antalya Training and Research Hospital: NGAL; Prostatectomy; Acute kidney injury

Study Results

No Results Posted as of Dec 19, 2018