Early Metabolic Support as a Potential Solution to Multi-Organ Dysfunction Syndrome (MODS) During Severe Sepsis

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.

Study Overview

• Status: Withdrawn
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: Insulin Drip; Dietary supplement: Liquid Nutrition

Detailed Description

Study Groups and Procedures:

If participant is eligible and chooses to take part in this study, they will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

Group 1 will receive standard-of-care treatment alone for up to 7 days.

Group 2 will receive standard treatment for up to 7 days, plus liquid nutrition. The liquid nutrition will be given by vein non-stop for up to 7 days. The liquid nutrition therapy may stop sooner if participant's doctor thinks they are ready, based on how they are tolerating tube feeding.

Both Groups: As part of standard treatment, participants will receive breathing and blood pressure support, daily routine blood draws, imaging, standard drugs (such as antibiotics and blood pressure drugs), and other tests the doctor decides are needed. These tests and treatment will begin within 12 hours after participant is admitted to the ICU.

Participant's doctor will discuss the standard treatment and tests with them in more detail. Participant may ask the study staff for information about how the standard treatment and tests are given and their risks.

If participant is in Group 2, blood (about 4 teaspoons) will be drawn on Days 1-7 to check their blood oxygen and sugar levels. These tests may help the doctor make any needed changes to participant's liquid nutrition therapy.

Length of Participation:

Participant will take part in this study for up to 7 days. Patient's participation on this study will be over after Day 7 or when they can leave the ICU, whichever happens first. Participant may be taken off study early if intolerable side effects occur or if they are unable to follow study directions.

This is an investigational study. The liquid nutrition provided in this study is FDA approved and commercially available. Comparing the 2 study groups is investigational. The study doctor can explain how the liquid nutrition is designed to work.

Up to 50 participants will be enrolled in this study. All will take part at MD Anderson.

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. All adult patients 18-years-old or greater
2. Admitted to the adult medical intensive unit (MICU) of MD Anderson Cancer Center
3. 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)
4. Diagnosis of Septic Shock within 12 hours of MICU admission defined as meeting criteria for sepsis (see inclusion criteria C) in addition to the following: 1) Vasopressor therapy needed to elevate MAP >/= 65 mmg Hg and 2) Lactate > 2 mmol/L (18 mg/dL) after adequate fluid resuscitation
5. Sequential Organ Failure Assessment (SOFA) score meeting the following requirements: 1) Cardiovascular SOFA >/= 2 and 2) Total SOFA score of less than 15
6. Diagnosis of leukemia, lymphoma, or status post stem cell transplantation
7. Patients in septic shock and not able to tolerate enteral nutrition above 70 percent of their daily nutritional caloric intake.

Exclusion Criteria:

1. Children (patients < 18-years-old) of age are not admitted to the MICU but to the pediatric intensive care unit (PICU)
2. Do Not Resuscitate (DNR), Comfort Care or Moribund
3. Death expected within the next 24 hours
4. Active Bleeding
5. End-stage Renal Disease (ESRD)
6. Chronic Liver Disease: Childs-Pugh Class C and/or Diagnosis of Cirrhosis
7. Tumor Lysis Syndrome
8. 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)
9. Serum sodium concentration < 130 milliequivalent (mEq)/L or >150 mEq/L (Note: Once serum sodium levels are >/= 130 or </= 150 mEq/L within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
10. Serum Creatinine level: SCr > 2.5 mg/dL (Note: Once serum creatinine levels are =/< 2.5 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
11. 11) Urine output < 400 cc/24hrs (Note: Once urine output levels are >/= 400 cc within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
12. Hyperkalemia K > 5.5 mEq/L (Note: Once potassium levels are </= 5.5 mEq/L within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
13. Hyperglycemia: Glucose > 250 mg/dL (Note: Once glucose is </= 250 mg/dL within 12 hours after meeting inclusion criteria, the patient can then be considered for the study. This is only a temporary restriction.)
14. Hyperphosphatemia: Serum Phosphorous > 8.0 mg/dL
15. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard-of-Care Treatment for Sepsis; 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; 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.; Other Names: Glucose Drip
Experimental: Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis; 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.	Procedure: Insulin Drip; 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.; Other Names: Glucose Drip; Dietary supplement: Liquid Nutrition; Participants receive liquid nutrition by vein non-stop for up to 7 days.; Other Names: Metabolic support; Enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Diego de Villalobos, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 26, 2016
• First Posted (Estimate): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2017
• Last Update Submitted That Met QC Criteria: February 23, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Septic Shock; Sepsis; Standard of care; Enteral nutrition; Liquid nutrition; Metabolic support; Insulin Drip; Glucose Drip
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Sepsis; Shock, Septic; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 2015-1014