← Back to Search

Other

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

No Placebo-Only Group

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 It's not suitable for those who can't walk, may have life support withdrawn within two days, prisoners, or pregnant women.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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 and 6 months post-hospital discharge

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met