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Clinical Trials/NCT02512224
NCT02512224
Completed
Not Applicable

Comparison of Short-term Mortality and Morbidity Between Parenteral and Enteral Nutrition for Adults Without Cancer: a Propensity-matched Analysis Using a National Inpatient Database

Tokyo University0 sites5,824 target enrollmentApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Deglutition Disorders
Sponsor
Tokyo University
Enrollment
5824
Primary Endpoint
Mortality Calculated From Outcome Section From DPC Database at 90 Days
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Short-term outcomes of parenteral and enteral nutrition for patients unable to eat normally were compared and analyzed.

Detailed Description

Data were acquired from patients selected from a national inpatient database covering 1,057 hospitals in Japan. Participants had received artificial nutrition between April 2012 and March 2013, were 20 years or older, and did not have cancer. Participants were grouped into two groups: those receiving parenteral nutrition and those receiving enteral nutrition. The investigators performed one-to-one propensity-score matching between the groups. The primary outcome measurements were mortality rates at 30 and 90 days after the start of the procedure. The secondary outcomes were post-procedural complications, pneumonia, and sepsis. The investigators analyzed survival length of stay after the procedure using a Cox proportional hazards model.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
December 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tokyo University
Responsible Party
Principal Investigator
Principal Investigator

Sumito Ogawa

Associate Professor

Tokyo University

Eligibility Criteria

Inclusion Criteria

  • investigators selected participants aged 20 years or older who had undergone either parenteral nutrition by central venous port insertion or enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31,
  • Patients who received both gastrostomy and central venous port insertion were assigned to the gastrostomy group.

Exclusion Criteria

  • investigators excluded participants who had been diagnosed with cancer.

Outcomes

Primary Outcomes

Mortality Calculated From Outcome Section From DPC Database at 90 Days

Time Frame: 90 days after the start of the procedure

Secondary Outcomes

  • Post-procedural Pneumonia(the incidence of post-procedural pneumonia occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.)
  • Post-procedural Sepsis(the incidence of post-procedural sepsis occurring during hospitalization. Participants will be followed for the duration of hospital stay, an expected median of 3 weeks after procedure.)
  • Re-admission 30 Days(re-admission within 30 days of discharge.)
  • Mortality Calculated From Outcome Section From DPC Database at 14 Days(14 days after the start of the procedure)
  • Mortality Calculated From Outcome Section From DPC Database at 30 Days(30 days after the start of the procedure)

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