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

NCT04773080 | Completed

• 1 other identifier: 3073
• Study Type: observational
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative acute kidney injury

  according to KDIGO criteria

  within 48 hours after surgery

Secondary Outcomes (7)

• Incidence of transient or persistent postoperative acute kidney injury

  48 hours after development of acute kidney injury

• Number of patients with renal recovery

  at 7 days, after 30 days and 3 months

• Incidence of postoperative pulmonary complications

  within 30 days after surgery

• Incidence of major adverse cardiac and cerebrovascular events (MACCE)

  within 30 days after surgery

• Incidence of sepsis

  within 30 days after surgery

Study Arms (1)

esophageal cancer surgery

patients undergoing elective esophageal surgery for cancer

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who underwent elective esophageal surgery for cancer

You may qualify if:

• Elective esophagectomy

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda Ospedaliera di Padova: lead

Study Sites (1)

Azienda Ospedaliera di Padova

Padua, Veneto, 35120, Italy

Location

MeSH Terms

Conditions

Acute Kidney Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Ilaria Godi, MD

  Azienda Ospedaliera di Padova

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 26, 2021
• Study Start: January 21, 2021
• Primary Completion: February 25, 2023
• Study Completion: February 25, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

IT (1)