Clinical trial NCT02512224: Comparison of Outcomes Between Parenteral and Enteral Nutrition
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deglutition Disorders
Keywords: parenteral nutrition
enteral nutrition
Lead sponsor: Tokyo University
Sponsor class: OTHER
First posted: 2015-07-30
Enrollment: 5824
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
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.

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.

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, 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.

Primary outcomes:
measure: Mortality Calculated From Outcome Section From DPC Database at 90 Days
timeFrame: 90 days after the start of the procedure
Secondary outcomes:
measure: Post-procedural Pneumonia
timeFrame: 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.
measure: Post-procedural Sepsis
timeFrame: 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.
measure: Re-admission 30 Days
timeFrame: re-admission within 30 days of discharge.
measure: Mortality Calculated From Outcome Section From DPC Database at 14 Days
timeFrame: 14 days after the start of the procedure
measure: Mortality Calculated From Outcome Section From DPC Database at 30 Days
timeFrame: 30 days after the start of the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Tokyo University
name: Sumito Ogawa, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.