Acute Kidney InjuryNCT04773080
Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery
An observational study of Acute Kidney Injury and Postoperative Complications, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Injury, Postoperative Complications
- How many people
- 254 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jan 2021to 25 Feb 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients who underwent elective esophageal surgery for cancer
Who may be able to join
- Elective esophagectomy
Who cannot join
- End-stage renal disease
- Missing data for acute kidney injury definition
- Second surgery (for patients having multiple surgeries performed during a 30-day period, only the first in each period will be included)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery: a Historical Cohort Study
Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. There is a paucity in the literature regarding postoperative renal outcomes after esophageal surgery, with a wide range of incidence.
The investigators will conduct a historical cohort study aiming to evaluate the incidence of postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery. Secondary, the investigators will assess the progression of the acute injury and the association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as increase in hospital stay and mortality. The investigators will also identify risk factors associated with acute kidney injury occurrence.
- Conditions
- Acute Kidney Injury, Postoperative Complications
- Medical subject headings
- Acute Kidney Injury, Postoperative Complications
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 |
|---|---|---|
| esophageal cancer surgery | patients undergoing elective esophageal surgery for cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative acute kidney injury
according to KDIGO criteria
Measured: within 48 hours after surgery
Secondary outcomes (7)
Incidence of transient or persistent postoperative acute kidney injury
according KDIGO criteria
Measured: 48 hours after development of acute kidney injury
Number of patients with renal recovery
according ADQI criteria
Measured: at 7 days, after 30 days and 3 months
Incidence of postoperative pulmonary complications
based on European Perioperative Clinical Outcome (EPCO) definitions
Measured: within 30 days after surgery
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
composite outcome of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina, ischemic stroke
Measured: within 30 days after surgery
Incidence of sepsis
according Sepsis-3 definition
Measured: within 30 days after surgery
Mortality in hospital
any death during the admission when the operation was performed
Measured: 1 year
Increase in length of hospital stay
compared to the expected length of hospital stay according ACS NSQIP calculation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start21 Jan 2021
- Primary completion25 Feb 2023
- Study completion25 Feb 2023
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.
- 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
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilaria Godi, Azienda Ospedaliera di Padova
- Investigators
- Ilaria Godi, MD, Principal investigator, Azienda Ospedaliera di Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04773080
- Sponsor's protocol ID
- 3073
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery: a Historical Cohort Study
- ClinicalTrials.gov ID
- NCT04773080
- Acronym / sponsor ID
- 3073
- Conditions
- Acute Kidney Injury, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 26 Feb 2021 (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.
Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative complications after esophagectomies for cancer is associated with a reduced long-term survival. There is a paucity in the literature regarding postoperative renal outcomes after esophageal surgery, with a wide range of incidence.
The investigators will conduct a historical cohort study aiming to evaluate the incidence of postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery. Secondary, the investigators will assess the progression of the acute injury and the association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as increase in hospital stay and mortality. The investigators will also identify risk factors associated with acute kidney injury occurrence.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| esophageal cancer surgery | – | –patients undergoing elective esophageal surgery for cancer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients who underwent elective esophageal surgery for cancer
Key inclusion criteria (1 listed)
- Elective esophagectomy
Key exclusion criteria (3 listed)
- End-stage renal disease
- Missing data for acute kidney injury definition
- Second surgery (for patients having multiple surgeries performed during a 30-day period, only the first in each period will be included)
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 postoperative acute kidney injury
Time frame: within 48 hours after surgery
according to KDIGO criteria
7 secondary outcomes
Incidence of transient or persistent postoperative acute kidney injury
Time frame: 48 hours after development of acute kidney injury
Number of patients with renal recovery
Time frame: at 7 days, after 30 days and 3 months
Incidence of postoperative pulmonary complications
Time frame: within 30 days after surgery
Incidence of major adverse cardiac and cerebrovascular events (MACCE)
Time frame: within 30 days after surgery
Incidence of sepsis
Time frame: within 30 days after surgery
Mortality in hospital
Time frame: 1 year
Increase in length of hospital stay
Time frame: 1 year
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 28 Feb 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ilaria Godi, MD principal investigator
Azienda Ospedaliera di Padova
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 Postoperative Complications, run by Azienda Ospedaliera di Padova 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 1 inclusion and 3 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 28 Feb 2023. 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?
Incidence of postoperative acute kidney injury (time frame: within 48 hours after surgery). 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 28 Feb 2023.