Comparison of Outcomes Between Parenteral and Enteral Nutrition

Deglutition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512224
• Other study ID #: MHLW H26-Policy-011
• Secondary ID: MHLW H26-Special
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: September 10, 2015
• Start date: April 2012
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Tokyo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board of the University of Tokyo: Japan
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5824
• Est. completion date: December 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Deglutition Disorders

Intervention

Device:
• Parenteral nutrition
Participants are retrospectively selected with propensity score matching
• Enteral nutrition
Participants are retrospectively selected with propensity score matching

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tokyo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Calculated From Outcome Section From DPC Database at 90 Days		90 days after the start of the procedure	No
Secondary	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.	No
Secondary	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.	No
Secondary	Re-admission 30 Days		re-admission within 30 days of discharge.	No
Secondary	Mortality Calculated From Outcome Section From DPC Database at 14 Days		14 days after the start of the procedure	No
Secondary	Mortality Calculated From Outcome Section From DPC Database at 30 Days		30 days after the start of the procedure	No