Acute Kidney InjuryNCT05255510
Risk of Acute Kidney Injury in Living Liver Donor Surgery
An observational study of Acute Kidney Injury and Liver Transplant; Complications, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Acute kidney injury (AKI) is one of the most common complication after restricted fluid therapy for major surgery. The aim of this study is to evaluate the incidence of AKI as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria in living liver donor hepatectomy in which applied intraoperative… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Liver Transplant; Complications, Fluid and Electrolyte Imbalance
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2019to 10 Jun 2021
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: patients who underwent living liver donor hepatectomy
Who may be able to join
- patients who underwent living liver donor hepatectomy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Risk of Acute Kidney Injury After Living Donor Hepatectomy by Protocolized Fluid Restriction: Single-center Experience
Acute kidney injury (AKI) is one of the most common complication after restricted fluid therapy for major surgery. The aim of this study is to evaluate the incidence of AKI as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria in living liver donor hepatectomy in which applied intraoperative protocolized fluid restriction targeting a low central venous pressure (CVP) level and high pulse pressure variation (PPV) / systolic pressure variation (SPV).
Read the detailed description
Operative blood loss and need for transfusion are risk factors associated with mortality after partial hepatectomy. The low central venous pressure (CVP) anesthetic technique has been strongly advocated to minimize hepatic venous bleeding during hepatectomy. Low CVP technique for living donor hepatectomy may not be advantageous regarding the safety of healthy living donors. Safer, simpler, and more useful fluid management methods are, therefore, required to reduce blood loss and subsequent morbidity during living donor hepatectomy. Pulse pressure variation (PPV) and systolic pressure variation (SPV) are the dynamic parameters of hemodynamic used to access the volume status and fluid responsiveness in mechanically ventilated patients.
Based only on the serum creatinine increase, AKI occurs in 5-15% of hepatectomy patients.In this study, we aimed to evaluate the incidence of AKI based on the change of serum creatinine levels in living liver donor hepatectomy regarding intraoperative fluid restriction targeting low CVP levels and high PPV and SPV depending on our protocolized fluid management.
130 living liver donors were admitted for a retrospective observational study. The low central venous pressure (<5 mmHg) and high pulse pressure variation (PPV<20%) / systolic pressure variation (SPV<15%) were applied to reduce intraoperative blood loss as fluid management until the end of the hepatic parenchymal division. AKI was defined using the KDIGO criteria according to the serum creatinine. The SPSS 11.5 program was used for statistical analysis.
- Keywords
- Living donors, acute kidney injury, central venous pressure, Hemodynamic Monitoring, fluid therapy
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute kidney injury in living donor patients
Kidney Disease Improving Global Outcomes (KDIGO) criteria
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start10 Oct 2019
- Primary completion1 Jun 2020
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Elvan Onur Kırımker, Sevcan Büyük, Elif Beyza Baskan, Ali Abbas Yılmaz, Deniz Balcı, Kaan Karayalçın, Mustafa Kemal Bayar
- Responsible party
- Principal investigator, Süheyla Karadağ Erkoç, Ankara University
- Investigators
- Süheyla Karadağ Erkoç, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255510
- Sponsor's protocol ID
- AnkaraUni
- Status last verified
- May 2022
- First submitted
- 14 Feb 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Risk of Acute Kidney Injury After Living Donor Hepatectomy by Protocolized Fluid Restriction: Single-center Experience
- ClinicalTrials.gov ID
- NCT05255510
- Acronym / sponsor ID
- AnkaraUni
- Keywords
- Living donors, acute kidney injury, central venous pressure, Hemodynamic Monitoring, fluid therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Elvan Onur Kırımker, Sevcan Büyük, Elif Beyza Baskan, Ali Abbas Yılmaz, Deniz Balcı, Kaan Karayalçın, Mustafa Kemal Bayar
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 24 Feb 2022 (actual)
- 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.
Acute kidney injury (AKI) is one of the most common complication after restricted fluid therapy for major surgery. The aim of this study is to evaluate the incidence of AKI as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria in living liver donor hepatectomy in which applied intraoperative protocolized fluid restriction targeting a low central venous pressure (CVP) level and high pulse pressure variation (PPV) / systolic pressure variation (SPV).
Detailed description
Operative blood loss and need for transfusion are risk factors associated with mortality after partial hepatectomy. The low central venous pressure (CVP) anesthetic technique has been strongly advocated to minimize hepatic venous bleeding during hepatectomy. Low CVP technique for living donor hepatectomy may not be advantageous regarding the safety of healthy living donors. Safer, simpler, and more useful fluid management methods are, therefore, required to reduce blood loss and subsequent morbidity during living donor hepatectomy. Pulse pressure variation (PPV) and systolic pressure variation (SPV) are the dynamic parameters of hemodynamic used to access the volume status and fluid responsiveness in mechanically ventilated patients.
Based only on the serum creatinine increase, AKI occurs in 5-15% of hepatectomy patients.In this study, we aimed to evaluate the incidence of AKI based on the change of serum creatinine levels in living liver donor hepatectomy regarding intraoperative fluid restriction targeting low CVP levels and high PPV and SPV depending on our protocolized fluid management.
130 living liver donors were admitted for a retrospective observational study. The low central venous pressure (<5 mmHg) and high pulse pressure variation (PPV<20%) / systolic pressure variation (SPV<15%) were applied to reduce intraoperative blood loss as fluid management until the end of the hepatic parenchymal division. AKI was defined using the KDIGO criteria according to the serum creatinine. The SPSS 11.5 program was used for statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who underwent living liver donor hepatectomy
Key inclusion criteria (1 listed)
- patients who underwent living liver donor hepatectomy
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute kidney injury in living donor patients
Time frame: one week
Kidney Disease Improving Global Outcomes (KDIGO) criteria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
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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.
Süheyla Karadağ Erkoç principal investigator
Ankara University
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 and Liver Transplant; Complications, run by Ankara University at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 12 May 2022. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Acute kidney injury in living donor patients (time frame: one week). 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 May 2022.