- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02873624
Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nahariya, Israel, 22100
- Western Galilee Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of AKI following a laparoscopic cholecystectomy
Time Frame: Up to one week after the procedure
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kidney function, included estimated GFR and urinary markers will be measured
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Up to one week after the procedure
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WGH160112ctil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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