NCT02885688

Brief Summary

The goal of this clinical research study is to learn if adding liquid nutrition therapy that is given by vein to standard-of-care treatment for sepsis can help to control sepsis symptoms better than giving standard-of-care treatment alone. Researchers also want to compare the length of ICU and hospital stay and any side effects between these 2 treatments.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

August 17, 2016

Last Update Submit

February 23, 2017

Conditions

Septic Shock

Keywords

Septic ShockSepsisStandard of careLiquid nutritionMetabolic supportEnteral nutritionInsulin DripGlucose Drip

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Accrual

    Trial feasible if ≥ 50% of eligible patients consent (i.e., approach 100 patients to achieve 50 that consent).

    7 days

  • Feasibility of Early Metabolic Support in Participants with Sepsis Determined by Adherence

    Trial feasible if ≥ 60% of enrolled patients complete the treatments up to 7 days or upon discharge from the ICU, whichever comes first.

    7 days

Study Arms (2)

Standard-of-Care Treatment for Sepsis

OTHER

Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment alone for up to 7 days.

Procedure: Insulin Drip

Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis

EXPERIMENTAL

Participants with diagnosis of septic shock in MD Anderson Cancer Center ICU receive standard of care treatment plus plus liquid nutrition for up to 7 days.

Dietary Supplement: Liquid NutritionProcedure: Insulin Drip

Interventions

Liquid NutritionDIETARY_SUPPLEMENT

Participants receive liquid nutrition by vein non-stop for up to 7 days.

Also known as: Metabolic support, Enteral nutrition
Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis
Insulin DripPROCEDURE

Insulin drip by vein to keep serum glucose level between 140 and 180 mg/dL as per ICU protocol. The interventions required in the current standard management of patients with septic shock is based on the MD Anderson Evidence-Based Protocol (EBP) for management of Severe Sepsis initiated on admission to the ICU.

Also known as: Glucose Drip
Standard-of-Care Treatment Plus Liquid Nutrition for SepsisStandard-of-Care Treatment for Sepsis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adult patients 18-years-old or greater
  • Admitted to the adult medical intensive unit (MICU) of MD Anderson Cancer Center
  • Diagnosis of Sepsis within 12 hours of MICU admission defined as: 1) Suspected or documented infection and 2) Acute increase of \>/= 2 SOFA points (a proxy for organ dysfunction)
  • Sequential Organ Failure Assessment (SOFA) score meeting the following requirements: 1) Cardiovascular SOFA \>/= 2 and 2) Total SOFA score of less than 15
  • Diagnosis of leukemia, lymphoma, or status post stem cell transplantation
  • Patients in septic shock and not able to tolerate enteral nutrition above 70 percent of their daily nutritional caloric intake.

You may not qualify if:

  • Children (patients \< 18-years-old) of age are not admitted to the MICU but to the pediatric intensive care unit (PICU)
  • Do Not Resuscitate (DNR), Comfort Care or Moribund
  • Death expected within the next 24 hours
  • Active Bleeding
  • End-stage Renal Disease (ESRD)
  • Chronic Liver Disease: Childs-Pugh Class C and/or Diagnosis of Cirrhosis
  • Tumor Lysis Syndrome
  • Sulfite Allergy: Hepatamine contraindicated. More common in asthmatics. (Please note that this is NOT sulfa allergy and is NOT contraindicated in patients with sulfa allergy)
  • Hyperphosphatemia: Serum Phosphorous \> 8.0 mg/dL
  • Patient with a history of metabolic abnormality in any one of the following amino acids: Alanine, Arginine, Cysteine hydrochloride, Glycine, Histidine, Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Phosphoric ac-id, Proline, Serine, Threonine, Tryptophan, and Valine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Diego de Villalobos, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2016

First Posted

August 31, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2018

Last Updated

February 24, 2017

Record last verified: 2017-02