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Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery

Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery: a Historical Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04773080
Enrollment
254
Registered
2021-02-26
Start date
2021-01-21
Completion date
2023-02-25
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Postoperative Complications

Brief 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. 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.

Interventions

None listed

Sponsors

Azienda Ospedaliera di Padova
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Elective esophagectomy

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative acute kidney injurywithin 48 hours after surgeryaccording to KDIGO criteria

Secondary

MeasureTime frameDescription
Number of patients with renal recoveryat 7 days, after 30 days and 3 monthsaccording ADQI criteria
Incidence of postoperative pulmonary complicationswithin 30 days after surgerybased on European Perioperative Clinical Outcome (EPCO) definitions
Incidence of major adverse cardiac and cerebrovascular events (MACCE)within 30 days after surgerycomposite outcome of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina, ischemic stroke
Incidence of transient or persistent postoperative acute kidney injury48 hours after development of acute kidney injuryaccording KDIGO criteria
Mortality in hospital1 yearany death during the admission when the operation was performed
Increase in length of hospital stay1 yearcompared to the expected length of hospital stay according ACS NSQIP calculation
Incidence of sepsiswithin 30 days after surgeryaccording Sepsis-3 definition

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026