Clincosm LogoSign in Get a demo

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

Sponsor
Azienda Ospedaliera di Padova (Other)
Overall Status
Recruiting
CT.gov ID
NCT04773080
Collaborator
(none)
430
Enrollment
1
Location
17
Anticipated Duration (Months)
25.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    430 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery: a Historical Cohort Study
    Actual Study Start Date :
    Jan 21, 2021
    Anticipated Primary Completion Date :
    Jun 21, 2022
    Anticipated Study Completion Date :
    Jun 21, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    esophageal cancer surgery

    patients undergoing elective esophageal surgery for cancer

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative acute kidney injury [within 48 hours after surgery]

      according to KDIGO criteria

    Secondary Outcome Measures

    1. Incidence of transient or persistent postoperative acute kidney injury [48 hours after development of acute kidney injury]

      according KDIGO criteria

    2. Number of patients with renal recovery [at 7 days, after 30 days and 3 months]

      according ADQI criteria

    3. Incidence of postoperative pulmonary complications [within 30 days after surgery]

      based on European Perioperative Clinical Outcome (EPCO) definitions

    4. Incidence of major adverse cardiac and cerebrovascular events (MACCE) [within 30 days after surgery]

      composite outcome of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina, ischemic stroke

    5. Incidence of sepsis [within 30 days after surgery]

      according Sepsis-3 definition

    6. Mortality in hospital [1 year]

      any death during the admission when the operation was performed

    7. Increase in length of hospital stay [1 year]

      compared to the expected length of hospital stay according ACS NSQIP calculation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Azienda Ospedaliera di Padova Padova Veneto Italy 35120

    Sponsors and Collaborators

    • Azienda Ospedaliera di Padova

    Investigators

    • Principal Investigator: Ilaria Godi, MD, Azienda Ospedaliera di Padova

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Ilaria Godi, Principal Investigator, Azienda Ospedaliera di Padova
    ClinicalTrials.gov Identifier:
    NCT04773080
    Other Study ID Numbers:
    • 3073
    First Posted:
    Feb 26, 2021
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Esophageal Neoplasms
    Acute Kidney Injury
    Postoperative Complications
    Wounds and Injuries

    Study Results

    No Results Posted as of Mar 4, 2022