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

Completed

• Conditions: Postoperative Complications; Acute Kidney Injury

• Registration Number: NCT04773080
• Lead Sponsor: Azienda Ospedaliera di Padova

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-21
• Study First Submitted: 2021-01-25
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-02-26
• Status Verified: 2023-02
• Primary Completion: 2023-02-25
• Study Completion: 2023-02-25
• Last Update Submitted: 2023-02-25
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative acute kidney injury	within 48 hours after surgery	according to KDIGO criteria

Secondary Outcome Measures

Name	Time	Method
Incidence of sepsis	within 30 days after surgery	according Sepsis-3 definition
Incidence of transient or persistent postoperative acute kidney injury	48 hours after development of acute kidney injury	according KDIGO criteria
Number of patients with renal recovery	at 7 days, after 30 days and 3 months	according ADQI criteria
Incidence of postoperative pulmonary complications	within 30 days after surgery	based on European Perioperative Clinical Outcome (EPCO) definitions
Increase in length of hospital stay	1 year	compared to the expected length of hospital stay according ACS NSQIP calculation
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
Mortality in hospital	1 year	any death during the admission when the operation was performed

Trial Locations

Locations (1)

Azienda Ospedaliera di Padova; 🇮🇹 Padova, Veneto, Italy