Trial Outcomes & Findings for Comparison of Outcomes Between Parenteral and Enteral Nutrition (NCT NCT02512224)

NCT ID: NCT02512224

Last Updated: 2015-09-30

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 5824 participants
• Primary outcome timeframe: 90 days after the start of the procedure
• Results posted on: 2015-09-30

Participant Flow

Participant milestones

Measure	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. Parenteral nutrition and Enteral 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Overall Study STARTED	2912	2912
Overall Study COMPLETED	2912	2912
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Outcomes Between Parenteral and Enteral Nutrition

Baseline characteristics by cohort

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Total n=5824 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	390 Participants n=93 Participants	354 Participants n=4 Participants	744 Participants n=27 Participants
Age, Categorical >=65 years	2522 Participants n=93 Participants	2558 Participants n=4 Participants	5080 Participants n=27 Participants
Age, Continuous	78.43 years STANDARD_DEVIATION 14.086 • n=93 Participants	78.81 years STANDARD_DEVIATION 13.558 • n=4 Participants	78.62 years STANDARD_DEVIATION 13.824 • n=27 Participants
Sex: Female, Male Female	1460 Participants n=93 Participants	1437 Participants n=4 Participants	2897 Participants n=27 Participants
Sex: Female, Male Male	1452 Participants n=93 Participants	1475 Participants n=4 Participants	2927 Participants n=27 Participants
Region of Enrollment Japan	2912 participants n=93 Participants	2912 participants n=4 Participants	5824 participants n=27 Participants

PRIMARY outcome

Timeframe: 90 days after the start of the procedure

Outcome measures

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Mortality Calculated From Outcome Section From DPC Database at 90 Days	359 Participants	287 Participants

SECONDARY outcome

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.

Outcome measures

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Post-procedural Pneumonia	346 Participants	450 Participants

SECONDARY outcome

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.

Outcome measures

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Post-procedural Sepsis	129 Participants	108 Participants

SECONDARY outcome

Timeframe: re-admission within 30 days of discharge.

Outcome measures

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Re-admission 30 Days	188 Participants	159 Participants

SECONDARY outcome

Timeframe: 14 days after the start of the procedure

Outcome measures

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Mortality Calculated From Outcome Section From DPC Database at 14 Days	114 Participants	89 Participants

SECONDARY outcome

Timeframe: 30 days after the start of the procedure

Outcome measures

Measure	Parenteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching	Enteral Nutrition n=2912 Participants 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. Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching
Mortality Calculated From Outcome Section From DPC Database at 30 Days	114 participants	89 participants

Adverse Events

Parenteral Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Enteral Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sumito Ogawa

The University of Tokyo Hospital

Phone: +81-3-5800-8830

Email: suogawa-tky@umin.ac.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place