Acute Kidney InjuryNCT06544538
Acute Kidney Injury After Cardiac Arrest
An observational study of Acute Kidney Injury, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The development of AKI (Acute Kidney Injury) after cardiac arrest is a common factor associated with mortality. In this study, we aimed to evaluate the factors that increase the risk of developing AKI after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2013to 31 Dec 2022
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Anesthesiology and Reanimation intensive care unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital after cardiac arrest
Who may be able to join
- adult patients with spontaneous circulation after cardiac arrest and admitted to the intensive care unit
Who cannot join
- Deaths in the first 48 hours
- Missing data
- End stage CKD or first day hemadsorption
- CPR time <3 min
- Unwitnessed cardiac arrest
- Terminal malignancy
Show all 11Show fewer
- 90 years old
- Having a pace marker
- Massive bleeding
- ECMO application
- First day diyabetes insipitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, 34140
About this study
Official title: Causes and Clinical Outcomes of Acute Kidney Injury After Cardiac Arrest: A Retrospective Cohort Study
The development of AKI (Acute Kidney Injury) after cardiac arrest is a common factor associated with mortality. In this study, we aimed to evaluate the factors that increase the risk of developing AKI after cardiac arrest.
For the study, patients were evaluated for the incidence of acute kidney injury (AKI), factors that increase the risk of AKI, and the impact of AKI on mortality. In this process, demographic data, comorbidities, hemodynamic data, laboratory data, clinical symptoms and findings recorded in the electronic decision support system were recorded and analyzed.
Read the detailed description
This retrospective study was performed on patients hospitalized in intensive care units after cardiac arrest between 2013 and 2022. Patients who met the inclusion criteria were included in the study. Urea, creatinine values, and whether AKI was diagnosed or not were obtained from the data registry system. Statistical evaluation was performed using univariate binary logistic regression analysis.
Demographic data, location of cardiac arrest (in-hospital, out-of-hospital), and duration of CPR were recorded. In addition, the causes of cardiac arrest, HR/MAP (heart rate/average arterial pressure) ratio, and whether VSP (vasopressor) or INO (inotropic) medication was needed were recorded.
- Conditions
- Acute Kidney Injury
- Keywords
- cardiac arrest, Acute kidney injury, Mortality
- Medical subject headings
- Acute Kidney Injury, Heart Arrest
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 |
|---|---|---|
| AKI Group | AKI 1-3 in the first 48 hours after cardiac arrest according to KDIGO 2012 criteria | |
| Non-AKI Group | Those who did not develop AKI in the first 48 hours after cardiac arrest according to KDIGO 2012 criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
Creatinine values in the first 48 hours of intensive care unit admission after cardiac arrest
Measured: Within 48 hours after intensive care unit admission
Secondary outcomes (2)
AKI incidence
Determination of the incidence of AKI development after cardiac arrest
Measured: Within 48 hours after intensive care unit admission
Mortality
Impact of AKI development on mortality in the early post-cardiac arrest period
Measured: Clinical and laboratory data within 48 hours after intensive care unit admission will be used
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- MURAT ASLAN, Dr, Principal investigator, Istanbul Bakırköy Dr Sadi Konuk Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544538
- Sponsor's protocol ID
- 2023/250
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available from the publication date can start If requested, data will be shared with medical doctors dealing with
Publications
Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25.
PubMed 33765189Kalogeris T, Baines CP, Krenz M, Korthuis RJ. Ischemia/Reperfusion. Compr Physiol. 2016 Dec 6;7(1):113-170. doi: 10.1002/cphy.c160006.
PubMed 28135002Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.
PubMed 23942856Adler C, Reuter H, Seck C, Hellmich M, Zobel C. Fluid therapy and acute kidney injury in cardiogenic shock after cardiac arrest. Resuscitation. 2013 Feb;84(2):194-9. doi: 10.1016/j.resuscitation.2012.06.013. Epub 2012 Jun 30.
PubMed 22750662Patyna S, Riekert K, Buettner S, Wagner A, Volk J, Weiler H, Erath-Honold JW, Geiger H, Fichtlscherer S, Honold J. Acute kidney injury after in-hospital cardiac arrest in a predominant internal medicine and cardiology patient population: incidence, risk factors, and impact on survival. Ren Fail. 2021 Dec;43(1):1163-1169. doi: 10.1080/0886022X.2021.1956538.
PubMed 34315321
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Clinical Outcomes of Acute Kidney Injury After Cardiac Arrest: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06544538
- Acronym / sponsor ID
- 2023/250
- Conditions
- Acute Kidney Injury
- Keywords
- cardiac arrest, Acute kidney injury, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 9 Aug 2024 (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.
The development of AKI (Acute Kidney Injury) after cardiac arrest is a common factor associated with mortality. In this study, we aimed to evaluate the factors that increase the risk of developing AKI after cardiac arrest.
For the study, patients were evaluated for the incidence of acute kidney injury (AKI), factors that increase the risk of AKI, and the impact of AKI on mortality. In this process, demographic data, comorbidities, hemodynamic data, laboratory data, clinical symptoms and findings recorded in the electronic decision support system were recorded and analyzed.
Detailed description
This retrospective study was performed on patients hospitalized in intensive care units after cardiac arrest between 2013 and 2022. Patients who met the inclusion criteria were included in the study. Urea, creatinine values, and whether AKI was diagnosed or not were obtained from the data registry system. Statistical evaluation was performed using univariate binary logistic regression analysis.
Demographic data, location of cardiac arrest (in-hospital, out-of-hospital), and duration of CPR were recorded. In addition, the causes of cardiac arrest, HR/MAP (heart rate/average arterial pressure) ratio, and whether VSP (vasopressor) or INO (inotropic) medication was needed were recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AKI Group | – | –AKI 1-3 in the first 48 hours after cardiac arrest according to KDIGO 2012 criteria |
| Non-AKI Group | – | –Those who did not develop AKI in the first 48 hours after cardiac arrest according to KDIGO 2012 criteria |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Anesthesiology and Reanimation intensive care unit of Bakırköy Dr. Sadi Konuk Training and Research Hospital after cardiac arrest
Key inclusion criteria (1 listed)
- adult patients with spontaneous circulation after cardiac arrest and admitted to the intensive care unit
Key exclusion criteria (11 listed)
- Deaths in the first 48 hours
- Missing data
- End stage CKD or first day hemadsorption
- CPR time <3 min
- Unwitnessed cardiac arrest
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 (AKI)
Time frame: Within 48 hours after intensive care unit admission
Creatinine values in the first 48 hours of intensive care unit admission after cardiac arrest
2 secondary outcomes
AKI incidence
Time frame: Within 48 hours after intensive care unit admission
Mortality
Time frame: Clinical and laboratory data within 48 hours after intensive care unit admission will be used
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 9 Aug 2024.
- Background: PubMed 33765189Nolan JP, Sandroni C, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Haywood K, Lilja G, Moulaert VRM, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone F, Soar J. European Resuscitation Council and European Society of Intensive Care Medicine guidelines 2021: post-resuscitation care. Intensive Care Med. 2021 Apr;47(4):369-421. doi: 10.1007/s00134-021-06368-4. Epub 2021 Mar 25.
- Background: PubMed 28135002Kalogeris T, Baines CP, Krenz M, Korthuis RJ. Ischemia/Reperfusion. Compr Physiol. 2016 Dec 6;7(1):113-170. doi: 10.1002/cphy.c160006.
- Background: PubMed 23942856Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.
- Background: PubMed 22750662Adler C, Reuter H, Seck C, Hellmich M, Zobel C. Fluid therapy and acute kidney injury in cardiogenic shock after cardiac arrest. Resuscitation. 2013 Feb;84(2):194-9. doi: 10.1016/j.resuscitation.2012.06.013. Epub 2012 Jun 30.
- Background: PubMed 34315321Patyna S, Riekert K, Buettner S, Wagner A, Volk J, Weiler H, Erath-Honold JW, Geiger H, Fichtlscherer S, Honold J. Acute kidney injury after in-hospital cardiac arrest in a predominant internal medicine and cardiology patient population: incidence, risk factors, and impact on survival. Ren Fail. 2021 Dec;43(1):1163-1169. doi: 10.1080/0886022X.2021.1956538.
- Individual participant dataSharing planned: Yes. Data available from the publication date can start If requested, data will be shared with medical doctors dealing with
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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.
MURAT ASLAN, Dr principal investigator
Istanbul Bakırköy Dr Sadi Konuk Training and Research Hospital
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, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 11 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 9 Aug 2024. 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 (AKI) (time frame: Within 48 hours after intensive care unit admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06544538, which also lists 5 linked publications.
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 9 Aug 2024.