Back to results

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

Primary Purpose

Septic Shock

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Liquid Nutrition

Insulin Drip

About this trial

This is an interventional supportive care trial for Septic Shock focused on measuring Septic Shock, Sepsis, Standard of care, Liquid nutrition, Metabolic support, Enteral nutrition, Insulin Drip, Glucose Drip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)
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
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.

Exclusion Criteria:

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)
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.)
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) 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.)
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.)
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.)
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard-of-Care Treatment for Sepsis

Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02885688

First Posted

August 17, 2016

Last Updated

February 23, 2017

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02885688

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Withdrawn

Study Start Date

October 2016 (undefined)

Primary Completion Date

October 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septic Shock

Keywords

Septic Shock, Sepsis, Standard of care, Liquid nutrition, Metabolic support, Enteral nutrition, Insulin Drip, Glucose Drip

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard-of-Care Treatment for Sepsis

Arm Type

Other

Arm Description

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

Arm Title

Standard-of-Care Treatment Plus Liquid Nutrition for Sepsis

Arm Type

Experimental

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Liquid Nutrition

Other Intervention Name(s)

Metabolic support, Enteral nutrition

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Insulin Drip

Other Intervention Name(s)

Glucose Drip

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

7 days

Title

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

Description

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

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) 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 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. Exclusion Criteria: 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) 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.) 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) 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.) 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.) 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.) 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diego de Villalobos, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

12. IPD Sharing Statement

Links:

URL

http://www.mdanderson.org

Description

University of Texas MD Anderson Cancer Center Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs