Comparison of Outcomes Between Parenteral and Enteral Nutrition

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

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

Study Overview

• Status: Completed
• Conditions: Deglutition Disorders
• Intervention / Treatment: Device: Parenteral nutrition; Device: Enteral nutrition

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 Type: Observational
• Enrollment (Actual): 5824

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For this study, the investigators used the Japanese Diagnosis Procedure Combination database, the details of which have been described elsewhere. The database includes administrative claims and discharge abstract data. In 2012, these data were collected for about seven million inpatients from 1,057 participating hospitals across Japan, which amounted to about half of the acute-care hospitalizations in the country.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Parenteral nutrition; Participants are retrospectively selected with propensity score matching
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.	Device: Enteral nutrition; Participants are retrospectively selected with propensity score matching

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tokyo University
• Investigators: Principal Investigator: Sumito Ogawa, MD. PhD., Tokyo University

Publications and helpful links

General Publications

• Tamiya H, Yasunaga H, Matusi H, Fushimi K, Akishita M, Ogawa S. 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. Am J Clin Nutr. 2015 Nov;102(5):1222-8. doi: 10.3945/ajcn.115.111831. Epub 2015 Oct 7.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 28, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: September 10, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: enteral nutrition; parenteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: MHLW H26-Policy-011; MHLW H26-Special-047 (Other Grant/Funding Number: Ministry of Health, Labour and Welfare, Japan); NCGG 25-11 (Other Grant/Funding Number: National Center for Geriatrics and Gerontology , Japan)