NCT02873624

Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acute Kidney Injury ,Laparoscopic Cholecystectomy

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic cholecystectomy

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-12-30
• Completion: 2018-12-31
• First posted: 2016-08-19
• Last updated: 2019-06-12

Locations

1 site across 1 country: Israel