Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

Terminated

• Conditions: Acute Kidney Injury ,Laparoscopic Cholecystectomy

• Registration Number: NCT02873624
• Lead Sponsor: Western Galilee Hospital-Nahariya

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.

Detailed Description

Introduction: Laparoscopic procedure produces adverse effects on splanchnic organs. Pneumoperitoneum is a non-physiologic condition that causes a higher intra-abdominal pressure (IAP) and is associated with significant direct and indirect effects on renal physiology.

Aim of the study:

To establish AKI incidence in patients who are undergoing laparoscopic cholecystectomy.

To identify the potential risk factors associated with the development of AKI. To establish the relationship between the IAP during the procedure and the AKI incidence.

Study Design:

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

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

Exclusion criteria: end stage renal disease, acute kidney injury or need of dialysis three months prior the procedure, acute infection, acute inflammation, BMI \> 40, malignancy and pregnancy.

The diagnosis of AKI will be made based on Kidney Disease Improving Global Outcomes (KDIGO) Clinical Practice Guideline 2012, by comparing the baseline and post-operative serum creatinine and cystatin C and monitoring urine output during the procedure and after the procedure for 24 hours.

Data Analysis: Results will be presented as mean ± standard deviation for quantitative data. A p value of \<0.05 will be considered statistically significant.

Study Timeline

• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2016-09
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-10
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of AKI following a laparoscopic cholecystectomy	Up to one week after the procedure	kidney function, included estimated GFR and urinary markers will be measured

Trial Locations

Locations (1)

Western Galilee Hospital; 🇮🇱 Nahariya, Israel