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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

SeND Home Trial 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 It's not suitable for those who can't walk, may have life support withdrawn within two days, prisoners, or pregnant women.Check my eligibility

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.See study design

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.

SeND Home Trial 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.

SeND Home Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in six-minute walk distance (6 MWD)

Secondary outcome measures

Change in Quality of Life (QoL)

Change in cognition

Change in key resilience and inflammation biomarkers

+7 more

SeND Home 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,367 Previous Clinical Trials

3,424,697 Total Patients Enrolled

1 Trials studying Abdominal Trauma

300 Patients Enrolled for Abdominal Trauma

United States Department of DefenseFED

865 Previous Clinical Trials

327,549 Total Patients Enrolled

1 Trials studying Abdominal Trauma

267 Patients Enrolled for Abdominal Trauma

Baxter Healthcare CorporationIndustry Sponsor

315 Previous Clinical Trials

199,918 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is SeND Home Pathway hazardous to individuals' health?

"Our team at Power believes that the SeND Home Pathway carries a safety rating of 2, due to there being some data on its security but no evidence yet regarding its efficacy."

Answered by AI

Is there still availability to join this experiment?

"Based on the information located at clinicaltrials.gov, this particular medical trial is no longer enrolling patients as it has not been updated since September 27th 2023. Nonetheless, there are a plethora of other studies requiring participants currently available for consideration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Nutrition to Improve Recovery in Trauma

2024. "Personalized Nutrition to Improve Recovery in Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06065202.

All > Trauma