Acute Kidney Injury ,Laparoscopic CholecystectomyNCT02873624
Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy
An observational study of Acute Kidney Injury ,Laparoscopic Cholecystectomy, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury ,Laparoscopic Cholecystectomy
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2016to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A single center prospective observational cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the Galilee Medical Center will be included.
Who may be able to join
- age > 18 years, able to sign the consent form, stable kidney function.
Who cannot join
- end stage renal disease
- acute kidney injury or need of dialysis three months prior the procedure
- acute infection
- acute inflammation
- malignancy
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- Acute Kidney Injury , Laparoscopic Cholecystectomy
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of AKI following a laparoscopic cholecystectomy
kidney function, included estimated GFR and urinary markers will be measured
Measured: Up to one week after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion30 Dec 2018
- Study completion31 Dec 2018
Why it stopped: No patients recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury ,Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Khaled Khazim, MD, Western Galilee Hospital-Nahariya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02873624
- Sponsor's protocol ID
- WGH160112ctil
- Status last verified
- Jun 2019
- First submitted
- 11 Aug 2016
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Acute Kidney Injury After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02873624
- Acronym / sponsor ID
- WGH160112ctil
- Keywords
- Acute Kidney Injury , Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No patients recruited
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Sep 2016 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A single center prospective observational cohort study will be conducted. 100 patients undergoing elective laparoscopic cholecystectomy in the Galilee Medical Center will be included.
Key inclusion criteria (1 listed)
- age > 18 years, able to sign the consent form, stable kidney function.
Key exclusion criteria (6 listed)
- end stage renal disease
- acute kidney injury or need of dialysis three months prior the procedure
- acute infection
- acute inflammation
- malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomy | Procedure or surgery | – |
Primary outcome
The incidence of AKI following a laparoscopic cholecystectomy
Time frame: Up to one week after the procedure
kidney function, included estimated GFR and urinary markers will be measured
Results and safety
The study was stopped early (reason given: No patients recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury ,Laparoscopic Cholecystectomy, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No patients recruited). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of AKI following a laparoscopic cholecystectomy (time frame: Up to one week after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.