Liver NeoplasmNCT06775158
Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection
An observational study of Liver Neoplasm and Kidney Injury, Acute, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Liver surgeries are high risk surgeries that might result in injuries in kidneys and heart. This study was planned to investigate the frequency of these injuries as well as the risk factors for their devolopment and its effect on patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Neoplasm, Kidney Injury, Acute, Myocardial Injury After Non-Cardiac Surgery
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2021to 30 Sep 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent resection in Hepatobiliary\&Pancreatic Surgery Clinic of Başakşehir Çam\&Sakura City Hospital, between june 2021 and june 2024
Who may be able to join
- Patients who underwent hepatic resection
Who cannot join
- presence of end stage kidney disease
- emergency surgery
- application of total vascular exclusion
- concomitant gastrointestinal resection
- duration of surgery less than 100 minutes
- non-oncologic procedures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam&Sakura City Hospital
Istanbul, 34480
About this study
Official title: Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection: Incidence, Risk Factors, Predictors and Relation with Patient Outcomes: a Retrospective Cohort Study
Liver surgeries are high risk surgeries that might result in injuries in kidneys and heart. This study was planned to investigate the frequency of these injuries as well as the risk factors for their devolopment and its effect on patient outcomes.
Read the detailed description
Hepatic resections are highly invasive major surgical procedures and are associated with higher incidence of end-organ injuries, specifically acute kidney injury (AKI) and perioperative myocardial injury (PMI). This study was designed to determine the incidences of AKI and PMI, and reveal the risk factors for their development and investigate intraoperative labaratory predictors in patients undergoing hepatic resection. We also planned to evaluate the relationship between the occurrence of end-organ injury and length of hospital and intensive care unit (ICU) stay, and 90-day mortality.
Patients were identified from a prospectively maintained data file that involves the perioperative data of patients undergoing surgery at Hepatobiliary-Pancreas clinic of Başakşehir Çam\&Sakura City Hospital. All consequtive patients within the study period were evaluated for inclusion. 128 patients were eligible for statistical analysis. This sample size was sufficient to determine the incidence of perioperative organ injury with a margin error of 8.4%. Green formula revealed that the sample size was sufficient for evaluating 9 variables in a regression model.
- Keywords
- Hepatic resection, acute kidney injury, perioperative myocardial injury
- Medical subject headings
- Liver Neoplasms, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with organ injury | Patitents who suffered from AKI or PMI | |
| Patients without organ injury | Patitents who did not suffer from AKI or PMI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients sufferd from Acute Kidney injury
at least 0.3mg/dL or 50% increase from baseline creatinine levels within 3 days postoperatively is described as Acute Kidney İnjury. Data will be presented as frequency(percentage) and the margin error of the percentage
Measured: 3 days postoperatively
Number of patients suffered from Perioperative myocardial injury
At least 14 ng/L increase from baseline high sensitive Troponin T levels within 3 days psotoperatively is described as perioperative myocardial injury. Data will be presented as frequency(percentage) and the margin error of the percentage
Measured: 3 days postoperatively
Number of patients suffered from perioperative organ injury
Occurence of acute kidney injury or perioperative myocardial injury within 3 days in patients undergoing hepatic resection. Descriptions are clarified in the prior outcomes' description sections. Data will be presented as frequency(percentage) and the margin error of the percentage
Measured: 3 days postoperatively
Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury
Patients' demographic, medical and intraoperative characteristics will be evaluated in terms of the occurence of perioperative organ injury. Variables with the p value < 0,05 will be added to the logistic regression model.
Measured: 3 days postoperatively
Secondary outcomes (3)
Length of intensive care unit stay
Length of intensive care unit stay during postoperative period will be evaluated in patients who did and did not suffer from perioperative organ injury
Measured: 90 days postoperatively
Length of hospital stay
Length of hospital stay in the postoperative period, including intensive care will be evaluated in patients who did and did not suffer from perioperative organ injury
Measured: 90 days postoperatively
90-day mortality
90-day mortality following the surgery will be evaluated in patients who did and did not suffer from perioperative organ injury
Measured: 90 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Jun 2021
- Primary completion20 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmStudies 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
- Retrospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775158
- Sponsor's protocol ID
- 27..2024.297
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All raw data that will be used during the statitistical analysis will be shared by the primary investigator upon reosanable request
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Myocardial and Renal Injury in Patients Undergoing Hepatic Resection: Incidence, Risk Factors, Predictors and Relation with Patient Outcomes: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06775158
- Acronym / sponsor ID
- 27..2024.297
- Keywords
- Hepatic resection, acute kidney injury, perioperative myocardial injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 14 Jan 2025 (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.
Liver surgeries are high risk surgeries that might result in injuries in kidneys and heart. This study was planned to investigate the frequency of these injuries as well as the risk factors for their devolopment and its effect on patient outcomes.
Detailed description
Hepatic resections are highly invasive major surgical procedures and are associated with higher incidence of end-organ injuries, specifically acute kidney injury (AKI) and perioperative myocardial injury (PMI). This study was designed to determine the incidences of AKI and PMI, and reveal the risk factors for their development and investigate intraoperative labaratory predictors in patients undergoing hepatic resection. We also planned to evaluate the relationship between the occurrence of end-organ injury and length of hospital and intensive care unit (ICU) stay, and 90-day mortality.
Patients were identified from a prospectively maintained data file that involves the perioperative data of patients undergoing surgery at Hepatobiliary-Pancreas clinic of Başakşehir Çam\&Sakura City Hospital. All consequtive patients within the study period were evaluated for inclusion. 128 patients were eligible for statistical analysis. This sample size was sufficient to determine the incidence of perioperative organ injury with a margin error of 8.4%. Green formula revealed that the sample size was sufficient for evaluating 9 variables in a regression model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with organ injury | – | –Patitents who suffered from AKI or PMI |
| Patients without organ injury | – | –Patitents who did not suffer from AKI or PMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent resection in Hepatobiliary\&Pancreatic Surgery Clinic of Başakşehir Çam\&Sakura City Hospital, between june 2021 and june 2024
Key inclusion criteria (1 listed)
- Patients who underwent hepatic resection
Key exclusion criteria (6 listed)
- presence of end stage kidney disease
- emergency surgery
- application of total vascular exclusion
- concomitant gastrointestinal resection
- duration of surgery less than 100 minutes
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
Number of patients sufferd from Acute Kidney injury
Time frame: 3 days postoperatively
at least 0.3mg/dL or 50% increase from baseline creatinine levels within 3 days postoperatively is described as Acute Kidney İnjury. Data will be presented as frequency(percentage) and the margin error of the percentage
Number of patients suffered from Perioperative myocardial injury
Time frame: 3 days postoperatively
At least 14 ng/L increase from baseline high sensitive Troponin T levels within 3 days psotoperatively is described as perioperative myocardial injury. Data will be presented as frequency(percentage) and the margin error of the percentage
Number of patients suffered from perioperative organ injury
Time frame: 3 days postoperatively
Occurence of acute kidney injury or perioperative myocardial injury within 3 days in patients undergoing hepatic resection. Descriptions are clarified in the prior outcomes' description sections. Data will be presented as frequency(percentage) and the margin error of the percentage
Odds Ratios of Risk Factors for the Occurence of perioperartive organ injury
Time frame: 3 days postoperatively
Patients' demographic, medical and intraoperative characteristics will be evaluated in terms of the occurence of perioperative organ injury. Variables with the p value < 0,05 will be added to the logistic regression model.
3 secondary outcomes
Length of intensive care unit stay
Time frame: 90 days postoperatively
Length of hospital stay
Time frame: 90 days postoperatively
90-day mortality
Time frame: 90 days postoperatively
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 14 Jan 2025.
- Individual participant dataSharing planned: Yes. All raw data that will be used during the statitistical analysis will be shared by the primary investigator upon reosanable request
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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.
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 Liver Neoplasm and Kidney Injury, Acute, run by Istanbul Saglik Bilimleri 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 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: finished, as of the sponsor's last update on 14 Jan 2025. 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?
Number of patients sufferd from Acute Kidney injury (time frame: 3 days postoperatively). The study lists 4 primary outcomes in all. 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 14 Jan 2025.