SurgeryCreaPeriopNCT04341974
Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury
An observational study of Surgery and Malignancy, run by Careggi Hospital at 1 site in Italy.
Trial summary
The perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Malignancy, Acute Kidney Injury
- What is being tested?
- Serum creatinine
- How many people
- 423 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 31 Mar 2020
- 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: All patients were older than 18 years, underwent surgery under general anesthesia for oncological disease who underwent major elective general abdominal surgery from November 2016 to February 2017 at the Department of Anaesthesia of Careggi Hospital
Who may be able to join
- Adult patients
- Scheduled for elective surgery
- Surgery for oncological disease
Who cannot join
- Patients undergoing postoperative chemotherapy
- Patients who died within 12 month after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury: an Observational, Monocentric, Retrospective Study to Explore Physicians' Perception and Practice.
The perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long term for progression toward CKD. The incidence and risk factors associated with PO-AKI and renal function deterioration within a year postoperatively will be also evaluated.
- Conditions
- Surgery, Malignancy, Acute Kidney Injury, Cronich Kidney Disease
- Being tested
- Serum creatinine
- Keywords
- serum creatinine, kidney dysfunction
- Medical subject headings
- Neoplasms, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum creatinineDiagnostic test
Will be described: 1) the number of patients actually screened with postoperative serum creatinine and 2) the number of patients actually screened with the same parameter at the long-term after surgery
| Study group | Role | What they receive |
|---|---|---|
| surgical patients | Adult patients undergoing major elective general abdominal surgery for ontological disease Receives: Diagnostic Test: Serum creatinine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of serum creatinine as marker of acute kidney injury postoperively
Number of actual patients screened postoperatively
Measured: 3rd postoperative day
Secondary outcomes (3)
Incidence of acute kidney injury
Number of patients with a postoperative diagnostic increase of serum creatinine, in accordance with KDIGO guidelines
Measured: 3rd postoperative day
Adoption of serum creatinine as marker of long term kidney dysfunction
Number of actual patients screened at the long term
Measured: 12 month after surgery
Incidence of long term kidney dysfunction
Number of patients with a long term reduction in GFR greater than 10 ml/min with respect to the baseline
Measured: 12 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies 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
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Villa, Careggi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341974
- Sponsor's protocol ID
- CEAVC 13881/2018
- Acronym
- CreaPeriop
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be not shared
Publications
Villa G, De Rosa S, Scire Calabrisotto C, Nerini A, Saitta T, Degl'Innocenti D, Paparella L, Bocciero V, Allinovi M, De Gaudio AR, Ostermann M, Romagnoli S. Perioperative use of serum creatinine and postoperative acute kidney injury: a single-centre, observational retrospective study to explore physicians' perception and practice. Perioper Med (Lond). 2021 May 25;10(1):13. doi: 10.1186/s13741-021-00184-6.
PubMed 34030728
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Use of Serum Creatinine and Postoperative Acute Kidney Injury: an Observational, Monocentric, Retrospective Study to Explore Physicians' Perception and Practice.
- ClinicalTrials.gov ID
- NCT04341974
- Acronym / sponsor ID
- CreaPeriop / CEAVC 13881/2018
- Conditions
- Surgery, Malignancy, Acute Kidney Injury, Cronich Kidney Disease
- Keywords
- serum creatinine, kidney dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 10 Apr 2020 (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 perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. In particular, the physician's attitude toward use of sCr for identification of patients at risk for PO-AKI will be described, as well as the patients who should be reassessed in the long term for progression toward CKD. The incidence and risk factors associated with PO-AKI and renal function deterioration within a year postoperatively will be also evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical patients | – | Diagnostic Test: Serum creatinineAdult patients undergoing major elective general abdominal surgery for ontological disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients were older than 18 years, underwent surgery under general anesthesia for oncological disease who underwent major elective general abdominal surgery from November 2016 to February 2017 at the Department of Anaesthesia of Careggi Hospital
Key inclusion criteria (3 listed)
- Adult patients
- Scheduled for elective surgery
- Surgery for oncological disease
Key exclusion criteria (2 listed)
- Patients undergoing postoperative chemotherapy
- Patients who died within 12 month after surgery
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 |
|---|---|---|
| Serum creatinineWill be described: 1) the number of patients actually screened with postoperative serum creatinine and 2) the number of patients actually screened with the same parameter at the long-term after surgery | Diagnostic test | surgical patients |
Primary outcome
Adoption of serum creatinine as marker of acute kidney injury postoperively
Time frame: 3rd postoperative day
Number of actual patients screened postoperatively
3 secondary outcomes
Incidence of acute kidney injury
Time frame: 3rd postoperative day
Adoption of serum creatinine as marker of long term kidney dysfunction
Time frame: 12 month after surgery
Incidence of long term kidney dysfunction
Time frame: 12 month after surgery
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 Apr 2020.
- Derived from this study: PubMed 34030728Villa G, De Rosa S, Scire Calabrisotto C, Nerini A, Saitta T, Degl'Innocenti D, Paparella L, Bocciero V, Allinovi M, De Gaudio AR, Ostermann M, Romagnoli S. Perioperative use of serum creatinine and postoperative acute kidney injury: a single-centre, observational retrospective study to explore physicians' perception and practice. Perioper Med (Lond). 2021 May 25;10(1):13. doi: 10.1186/s13741-021-00184-6.
- Individual participant dataSharing planned: No. IPD will be not shared
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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 Surgery and Malignancy, run by Careggi Hospital at 1 site in Italy.
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 3 inclusion and 2 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 Apr 2020. 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 Italy. 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?
Adoption of serum creatinine as marker of acute kidney injury postoperively (time frame: 3rd postoperative day). 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 NCT04341974, which also lists 1 linked publication.
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 Apr 2020.