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OpenTrials
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NCT Number: NCT04773080

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera di Padova

Padova, Veneto, 35120, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative acute kidney injury

    Time frame: within 48 hours after surgery

    according to KDIGO criteria

Secondary outcomes

  1. Incidence of transient or persistent postoperative acute kidney injury

    Time frame: 48 hours after development of acute kidney injury

    according KDIGO criteria

  2. Number of patients with renal recovery

    Time frame: at 7 days, after 30 days and 3 months

    according ADQI criteria

  3. Incidence of postoperative pulmonary complications

    Time frame: within 30 days after surgery

    based on European Perioperative Clinical Outcome (EPCO) definitions

  4. Incidence of major adverse cardiac and cerebrovascular events (MACCE)

    Time frame: 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

    Time frame: within 30 days after surgery

    according Sepsis-3 definition

  6. Mortality in hospital

    Time frame: 1 year

    any death during the admission when the operation was performed

  7. Increase in length of hospital stay

    Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Padova

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 26, 2021
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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