Study Comparing Early and Late Nutrition in Cancer Patients Undergoing Abdominal Surgery (PaNCS)
Recruitment status was: Recruiting
|Cancer Abdominal Surgery Parenteral Nutrition||Dietary Supplement: Early parenteral nutrition Dietary Supplement: Late parenteral nutrition||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Early Versus Late Parenteral Nutrition in Cancer Patients Undergoing Abdominal Surgery|
- Clinical complications [ Time Frame: 30 days ]respiratory, cardiovascular, renal, neurological, infectious, surgical
- Mortality [ Time Frame: 30 days ]30-day mortality
- Length of stay in ICU and in hospital [ Time Frame: 30 days ]Length of stay
- ICU readmission rate [ Time Frame: 30 days ]
- Duration of pharmacologic hemodynamic support [ Time Frame: 30 days ]
- Levels of C-reactive protein [ Time Frame: 7 days ]
- Duration of mechanical ventilation [ Time Frame: 30 days ]
- Liver dysfunction [ Time Frame: 30 days ]
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Early parenteral nutrition
Parenteral nutrition starts at 2nd postoperative day.
|Dietary Supplement: Early parenteral nutrition|
Active Comparator: Late parenteral nutrition
Parenteral nutrition starts at 7th postoperative day.
|Dietary Supplement: Late parenteral nutrition|
There is a controversy regarding the timing of initiation of parenteral nutrition in cancer patients undergoing abdominal surgery in whom caloric targets cannot be met by enteral nutrition alone.
This is a randomized and controlled trial comparing early initiation with late initiation of parenteral nutrition.
Early-initiation group: patients will be randomized to initiate parenteral nutrition in the 2nd day after surgery.
Late-initiation group: patients will be randomized to initiate parenteral nutrition in the 7th day after surgery.
Calculations regarding the caloric goal included protein energy and were based on corrected ideal body weight, age and sex. When oral or enteral nutrition covered 80% of the calculated caloric goal, parenteral nutrition was reduced and progressively stopped.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01839617
|Contact: Patricia C Marques, MD||11-38933271|
|Sao Paulo, SP, Brazil, 01414001|
|Principal Investigator: Patricia C Moraes, MD|
|Sub-Investigator: Ludhmila A Hajjar, PhD|
|Cancer Institute of the State of Sao Paulo||Not yet recruiting|
|São Paulo, SP, Brazil, 01246-000|
|Contact: PATRÍCIA CAMARGO MARQUES UIC +55 11 3893-3267 firstname.lastname@example.org|
|Contact: ICESP UIC +55 11 3893-3267 email@example.com|