Acute Kidney InjuryNCT04130347
Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
An observational study of Acute Kidney Injury, run by Uppsala University.
Trial summary
Retrospective study that aims to examine the presence of acute kidney injury (AKI) during major abdominal surgery, non- cardiac surgery. Using clinical and biochemical data in order to establish AKI frequency and risk factors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 499 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 Sep 2017
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Swedish population undergoing cancer surgery with four selected procedures. Age span between 19 and 85 years old.
Who may be able to join
- Any of the selected procedures.
Who cannot join
- Patient has expressed his or her will to nor participate in any study.
About this study
Retrospective study that aims to examine the presence of acute kidney injury (AKI) during major abdominal surgery, non- cardiac surgery. Using clinical and biochemical data in order to establish AKI frequency and risk factors.
Read the detailed description
Ethical approval was submitted and approved by the regional ethical committee, Etisk prövningsnämnd Uppsala, # 2017/418.
Patients were selected from the time span of april 2016 to september 2017. The investigators identified 499 patients that had undergone any of the selected procedures. The procedures were, pancreatic resection, HIPEC surgery in colorectal setting, gynecological debulking in metastasized ovarian cancer, and liver resection.
The risk of acute kidney injury (AKI) by the KDIGO definition during the postoperative period will be estimated in the group as a whole, and for each type of surgery separately. In addition the data will be stratified by sex to investigate systematic gender disparities or physiological differences. Length of stay, thirty day and sixty day mortality will secondary endpoints.
- Conditions
- Acute Kidney Injury
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic resection | Not described | |
| Liver resection | Not described | |
| HIPEC surgery | Not described | |
| Gynecological debulking surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of AKI
Frequency of AKI as defined by KDIGO
Measured: the first 24- 72 hours postop
Secondary outcomes (4)
Mortality
30, 60, and 360 day mortality rate
Measured: 30, 60 and 360 days postoperatively
Major Adverse Kidney Events
Renal composite outcome according to Major Adverse Kidney Events (MAKE)
Measured: 30, 60 and 360 days postoperatively
Fluid balance
Fluid balance during surgery, and the first postoperative days.
Measured: 24-72h
Electrolyte disturbances
Any electrolyte disturbance.
Measured: 24-72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Apr 2016
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
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 Uppsala 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Hultström, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130347
- Sponsor's protocol ID
- EPN dnr 2017/218
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Major Abdominal Surgery: Retrospective Study of 501 Patients
- ClinicalTrials.gov ID
- NCT04130347
- Acronym / sponsor ID
- EPN dnr 2017/218
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 17 Oct 2019 (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.
Retrospective study that aims to examine the presence of acute kidney injury (AKI) during major abdominal surgery, non- cardiac surgery. Using clinical and biochemical data in order to establish AKI frequency and risk factors.
Detailed description
Ethical approval was submitted and approved by the regional ethical committee, Etisk prövningsnämnd Uppsala, # 2017/418.
Patients were selected from the time span of april 2016 to september 2017. The investigators identified 499 patients that had undergone any of the selected procedures. The procedures were, pancreatic resection, HIPEC surgery in colorectal setting, gynecological debulking in metastasized ovarian cancer, and liver resection.
The risk of acute kidney injury (AKI) by the KDIGO definition during the postoperative period will be estimated in the group as a whole, and for each type of surgery separately. In addition the data will be stratified by sex to investigate systematic gender disparities or physiological differences. Length of stay, thirty day and sixty day mortality will secondary endpoints.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pancreatic resection | – | – |
| Liver resection | – | – |
| HIPEC surgery | – | – |
| Gynecological debulking surgery | – | – |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Swedish population undergoing cancer surgery with four selected procedures. Age span between 19 and 85 years old.
Key inclusion criteria (1 listed)
- Any of the selected procedures.
Key exclusion criteria (1 listed)
- Patient has expressed his or her will to nor participate in any study.
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
Incidence of AKI
Time frame: the first 24- 72 hours postop
Frequency of AKI as defined by KDIGO
4 secondary outcomes
Mortality
Time frame: 30, 60 and 360 days postoperatively
Major Adverse Kidney Events
Time frame: 30, 60 and 360 days postoperatively
Fluid balance
Time frame: 24-72h
Electrolyte disturbances
Time frame: 24-72h
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 18 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Uppsala University.
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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of AKI (time frame: the first 24- 72 hours postop). 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 18 Oct 2019.