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Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02873624
Enrollment
100
Registered
2016-08-19
Start date
2016-09-30
Completion date
2018-12-31
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury ,Laparoscopic Cholecystectomy

Keywords

Acute Kidney Injury , Laparoscopic Cholecystectomy

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.

Interventions

PROCEDURELaparoscopic cholecystectomy

Sponsors

Western Galilee Hospital-Nahariya
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The incidence of AKI following a laparoscopic cholecystectomyUp to one week after the procedurekidney function, included estimated GFR and urinary markers will be measured

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026