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Completed

NCT Number: NCT02512224

Comparison of Outcomes Between Parenteral and Enteral Nutrition

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

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Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Hyperphagia Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parenteral nutrition

Device

Participants are retrospectively selected with propensity score matching

Enteral nutrition

Device

Participants are retrospectively selected with propensity score matching

Primary outcomes

  1. Mortality Calculated From Outcome Section From DPC Database at 90 Days

    Time frame: 90 days after the start of the procedure

Secondary outcomes

  1. Post-procedural Pneumonia

    Time frame: 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.

  2. Post-procedural Sepsis

    Time frame: 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.

  3. Re-admission 30 Days

    Time frame: re-admission within 30 days of discharge.

  4. Mortality Calculated From Outcome Section From DPC Database at 14 Days

    Time frame: 14 days after the start of the procedure

  5. Mortality Calculated From Outcome Section From DPC Database at 30 Days

    Time frame: 30 days after the start of the procedure

Sponsors and collaborators

Lead sponsor

Tokyo University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 30, 2015
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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