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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773080
• Other study ID #: 3073
• Status: Completed
• Start date: January 21, 2021
• Est. completion date: February 25, 2023

Study information

• Verified date: February 2023
• Source: Azienda Ospedaliera di Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: February 25, 2023
• Est. primary completion date: February 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Esophageal Neoplasms
• Postoperative Complications
• Wounds and Injuries

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera di Padova	Padova	Veneto

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative acute kidney injury	according to KDIGO criteria	within 48 hours after surgery
Secondary	Incidence of transient or persistent postoperative acute kidney injury	according KDIGO criteria	48 hours after development of acute kidney injury
Secondary	Number of patients with renal recovery	according ADQI criteria	at 7 days, after 30 days and 3 months
Secondary	Incidence of postoperative pulmonary complications	based on European Perioperative Clinical Outcome (EPCO) definitions	within 30 days after surgery
Secondary	Incidence of major adverse cardiac and cerebrovascular events (MACCE)	composite outcome of non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmia, angina, ischemic stroke	within 30 days after surgery
Secondary	Incidence of sepsis	according Sepsis-3 definition	within 30 days after surgery
Secondary	Mortality in hospital	any death during the admission when the operation was performed	1 year
Secondary	Increase in length of hospital stay	compared to the expected length of hospital stay according ACS NSQIP calculation	1 year