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Nutrition Supplements for Abdominal Trauma Recovery (SeND Home Trial)

Phase 2
Recruiting
Led By Paul Wischmeyer, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Admitted to the surgical ICU
Penetrating abdominal trauma requiring emergent major abdominal surgery
Must not have
Patients who are unable to ambulate at baseline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 and 6 months post-hospital discharge
Awards & highlights

Summary

This trial will compare two nutrition plans to see if one helps improve outcomes for trauma patients after abdominal surgery in the ICU.

Who is the study for?
This trial is for adults who've had emergency abdominal surgery due to trauma and are in the ICU, unable to eat normally for at least 72 hours. It's not suitable for those who can't walk, may have life support withdrawn within two days, prisoners, or pregnant women.
What is being tested?
The study tests a personalized nutrition plan (SeND Home pathway) involving TPN and oral supplements against standard care. Participants will be randomly assigned to either receive SeND Home with follow-up after hospital discharge or just the usual hospital care.
What are the potential side effects?
Potential side effects from the nutrition supplements could include digestive discomfort or reactions at the infusion site. However, specific side effects will depend on individual tolerance to TPN and oral supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am currently in the surgical intensive care unit.
Select...
I needed emergency surgery due to a severe injury to my abdomen.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot walk by myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 and 6 months post-hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 and 6 months post-hospital discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in six-minute walk distance (6 MWD)
Secondary study objectives
Change in Quality of Life (QoL)
Change in cognition
Change in key resilience and inflammation biomarkers
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SeND Home PathwayExperimental Treatment1 Intervention
Total parenteral nutrition (TPN) will begin within 72 hours of abdominal surgery. Calorie needs will be determined by indirect calorimetry. Nutritional shakes will begin when a liquid diet is started. These will be taken 3 times a day while in the hospital and for 4 weeks after discharge.
Group II: Standard NutritionActive Control1 Intervention
Standard nutrition as determined by clinical providers.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,065,934 Total Patients Enrolled
1 Trials studying Abdominal Trauma
300 Patients Enrolled for Abdominal Trauma
United States Department of DefenseFED
891 Previous Clinical Trials
332,328 Total Patients Enrolled
1 Trials studying Abdominal Trauma
267 Patients Enrolled for Abdominal Trauma
Baxter Healthcare CorporationIndustry Sponsor
318 Previous Clinical Trials
201,795 Total Patients Enrolled
~0 spots leftby Sep 2024
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