NCT02512224

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,824

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
1 month until next milestone

Results Posted

Study results publicly available

September 10, 2015

Completed
Last Updated

September 30, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 28, 2015

Results QC Date

August 5, 2015

Last Update Submit

September 10, 2015

Conditions

Deglutition Disorders

Keywords

parenteral nutritionenteral nutrition

Outcome Measures

Primary Outcomes (1)

  • Mortality Calculated From Outcome Section From DPC Database at 90 Days

    90 days after the start of the procedure

Secondary Outcomes (5)

  • 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

Study Arms (2)

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

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

Interventions

Parenteral nutritionDEVICE

Participants are retrospectively selected with propensity score matching

Parenteral nutrition
Enteral nutritionDEVICE

Participants are retrospectively selected with propensity score matching

Enteral nutrition

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • investigators excluded participants who had been diagnosed with cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26447149DERIVED

MeSH Terms

Conditions

Deglutition DisordersHyperphagia

Interventions

Parenteral NutritionEnteral Nutrition

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Results Point of Contact

Title
Dr. Sumito Ogawa
Organization
The University of Tokyo Hospital
suogawa-tky@umin.ac.jp
+81-3-5800-8830

Study Officials

  • Sumito Ogawa, MD. PhD.

    Tokyo University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 30, 2015

Study Start

April 1, 2012

Primary Completion

March 1, 2013

Study Completion

December 1, 2014

Last Updated

September 30, 2015

Results First Posted

September 10, 2015

Record last verified: 2015-09