Comparison of Outcomes Between Parenteral and Enteral Nutrition

Completed

• Conditions: Deglutition Disorders
• Interventions: Device: Parenteral nutrition; Device: Enteral nutrition

• Registration Number: NCT02512224
• Lead Sponsor: Tokyo University

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-03
• Study Completion: 2014-12
• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Results First Submitted: 2015-08-05
• Results First Submitted QC: 2015-08-12
• Status Verified: 2015-09
• Results First Posted: 2015-09-10
• Last Update Submitted: 2015-09-10
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5824

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, 2013. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parenteral nutrition	Parenteral nutrition	investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.
Enteral nutrition	Enteral nutrition	investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.

Primary Outcome Measures

Name	Time	Method
Mortality Calculated From Outcome Section From DPC Database at 90 Days	90 days after the start of the procedure

Secondary Outcome Measures

Name	Time	Method
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