Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

Acute Kidney Injury ,Laparoscopic Cholecystectomy Clinical Trial

Official title:

Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02873624
• Other study ID #: WGH160112ctil
• Status: Terminated
• Start date: September 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2019
• Source: Western Galilee Hospital-Nahariya
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 31, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury ,Laparoscopic Cholecystectomy
• Wounds and Injuries

Intervention

Procedure:
• Laparoscopic cholecystectomy

Locations

Country	Name	City	State
Israel	Western Galilee Hospital	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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