Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

NCT02873624 | Terminated DMC

• 1 other identifier: WGH160112ctil
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to establish AKI incidence in patients who are undergoing laparoscopic cholecystectomy and to identify the potential risk factors associated with the development of AKI.

Conditions

Acute Kidney Injury ,Laparoscopic Cholecystectomy

Keywords

Acute Kidney Injury , Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• The incidence of AKI following a laparoscopic cholecystectomy

  kidney function, included estimated GFR and urinary markers will be measured

  Up to one week after the procedure

Interventions

Laparoscopic cholecystectomy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A single center prospective observational cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the Galilee Medical Center will be included.

You may qualify if:

• age \> 18 years, able to sign the consent form, stable kidney function.

You may not qualify if:

• end stage renal disease
• acute kidney injury or need of dialysis three months prior the procedure
• acute infection
• acute inflammation
• malignancy
• pregnancy

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Western Galilee Hospital

Nahariya, 22100, Israel

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology specialist

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 19, 2016
• Study Start: September 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: June 12, 2019

Record last verified: 2019-06

Locations

IL (1)