Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

NCT ID: NCT02873624

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-12-31

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.

Conditions

Acute Kidney Injury ,Laparoscopic Cholecystectomy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Western Galilee Hospital-Nahariya

OTHER_GOV

Sponsor Role: lead

Responsible Party

Khaled Khazim, MD

Nephrology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Western Galilee Hospital

Nahariya, , Israel

Countries

Israel

Other Identifiers

WGH160112ctil

Identifier Type: -

Identifier Source: org_study_id