Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03477903
Other study ID # TAK-954-2002
Secondary ID U1111-1208-18312
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 25, 2018
Est. completion date August 29, 2018

Study information

Verified date September 2019
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the treatment effect of intravenous TAK-954 in improving the average daily protein adequacy received through enteral nutrition in critically-ill participants developing EFI.


Description:

The drug being tested in this study is called TAK-954. The study will assess the treatment effect of intravenous TAK-954 in improving average daily protein adequacy received through enteral nutrition in critically ill participants with EFI.

The study will enroll approximately 200 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment groups -which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

- Group A: TAK-954 0.1 mg

- Group B: TAK-954 0.3 mg

- Group C: TAK-954 1 mg

- Group D: Metoclopramide 10 mg

This multi-center trial will be conducted in the United States, United Kingdom, Australia and Canada. The overall duration of treatment in this study is maximum of 14 days while in hospital. Participants will be contacted by telephone 30 and 90 days after receiving their last dose of study drug for a follow-up assessment.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date August 29, 2018
Est. primary completion date August 29, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Has at least a size 12-(french size) Fr nasogastric or orogastric tube with its tip at least 10 centimeter (cm) below the esophagogastric junction confirmed radiologically (the tip of the tube must be in the body or the antrum of the stomach and not in the fundus).

2. Is intubated and mechanically ventilated in the ICU.

3. Is expected to remain alive, mechanically ventilated, and receive continuous enteral feeding for >=48 hours following randomization.

4. Have EFI, defined as a single GRV measurement of >=250 mL with vomiting/retching within the last 24 hours, or a single GRV measurement of >=500 mL with or without vomiting/retching within the last 24 hours.

Exclusion Criteria:

1. Is under consideration for withdrawal of life-sustaining treatments within the next 72 hours.

2. Has had major esophageal or gastric surgery or direct luminal trauma on this admission (participants with lower abdominal surgery are not excluded unless enteral feeding is contraindicated).

3. Has mechanical bowel obstruction, short bowel syndrome, or the presence of an active gastric pacemaker.

4. Have pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe; total score 10 to 15 points).

5. Has been admitted primarily for treatment of a drug overdose.

6. Has a presence of a post-pyloric tube in place at Randomization that may be used for enteral nutrition.

7. Is receiving parenteral nutrition (PN) at Screening.

8. Is in diabetic ketoacidosis or non-ketotic hyperosmolar coma.

9. Has a different nutrient requirement than allowed in feeding protocol.(outside a range of 1.2 to 2 gram per kilogram per day [g/kg/day] of proteins and up to 1.5 kilocalorie per milliliter [kcal/mL]).

Study Design


Intervention

Drug:
TAK-954
TAK-954 infusion
Metoclopramide
Metoclopramide infusion
Normal Saline
0.9% sodium chloride for injection

Locations

Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia Flinders Medical Centre Bedford Park South Australia
Australia Royal Brisbane and Women's Hospital Brisbane Queensland
Australia Monash Medical Centre Clayton Victoria
Australia The Northern Hospital Epping Victoria
Australia Frankston Hospital Frankston Victoria
Australia Logan Hospital Meadowbrook Queensland
Australia The Royal Melbourne Hospital Parkville Victoria
Australia Mater Hospital Brisbane South Brisbane Queensland
Australia Royal North Shore Hospital St. Leonards New South Wales
Canada Hopital Charles-LeMoyne Greenfield Park Quebec
Canada Kingston General Hospital Kingston Ontario
Canada Hopital du Sacre-Coeur de Montreal Monteal Quebec
Canada McGill University Health Centre Montreal Quebec
Canada Royal Columbian Hospital New Westminster British Columbia
Canada Centre Hospitalier Universitaire de Quebec Hospital Centre Hospitalier de IUniversite Laval Quebec
Canada St. Paul's Hospital Vancouver British Columbia
United Kingdom University Hospitals Birmingham NHS Foundation Trust Birmingham England
United Kingdom Royal Sussex County Hospital Brighton England
United Kingdom University Hospitals Bristol NHS Foundation Trust Bristol England
United Kingdom Cardiff and Vale University Health Board Cardiff Wales
United Kingdom NHS Lothian Edinburgh Scotland
United Kingdom NHS Greater Glasgow and Clyde Glasgow Scotland
United Kingdom The Leeds Teaching Hospitals NHS Trust Leeds England
United Kingdom Royal Liverpool University Hospital NHS Trust Liverpool
United Kingdom Guy's and Saint Thomas' NHS Foundation Trust London England
United Kingdom King's College Hospital NHS Foundation Trust London England
United Kingdom Royal Free London NHS Foundation Trust London England
United Kingdom The Royal London Hospital London England
United Kingdom Aneurin Bevan University Health Board Newport Wales
United States Anne Arundel Medical Center Annapolis Maryland
United States Joseph M Still Burn Centers Augusta Georgia
United States Cleveland Clinic Cleveland Ohio
United States Duke University Medical Center Durham North Carolina
United States Englewood Hospital and Medical Center Englewood New Jersey
United States The University of Texas Health Science Center at Houston Houston Texas
United States Eastern Idaho Medical Consultants Idaho Falls Idaho
United States Truman Medical Center Hospital Hill Kansas City Missouri
United States University of Kentucky Health Care Lexington Kentucky
United States New York-Presbyterian Columbia University Medical Center New York New York
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Creighton University Omaha Nebraska
United States Illinois Lung & Critical Care Institute Peoria Illinois
United States Froedtert Hospital Wauwatosa Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average Daily Protein Adequacy Over the First 5 Days of Treatment Average daily protein adequacy received through enteral nutrition is defined as the percentage of goal protein delivered per day, where percentage of goal protein delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 5 days was averaged. Days 1 to 5
Secondary Average Daily Protein Adequacy Over the Study Treatment Period Average daily protein adequacy received through enteral nutrition is defined as percentage of goal protein delivered per day, where percentage of protein goal delivered is calculated as the ratio of actual protein achievement to the total participant-specific target protein prescribed. The value for each of the 14 days was averaged. Days 1 to 14
Secondary Average Daily Change in 24-hour Gastric Residual Volume (GRV) Over the First 5 Days of Study Treatment GRV is defined as the volume of fluid remaining in the stomach at a point in time during enteral nutrition feeding. The value for each of the 5 days was averaged. Days 1 to 5
Secondary Average Daily Caloric Adequacy Average daily caloric adequacy received through enteral nutrition was defined by percentage of goal calories achieved per day (percentage calorie goal achieved=actual calorie achievement/total participant-specific target calories). The values in the 5-day period and the 14-day period were averaged. Days 1 to 5 and Days 1 to 14
Secondary Time to Resolution of Enteral Feeding Intolerance (EFI) Time to resolution of EFI is defined as the time needed to achieve GRV less than or equal to 250 ml in the absence of vomiting/retching. Days 1 to 14 or until resolution of EFI, whichever occurs first
Secondary Percentage of Participants Achieving at Least 80% of Daily Goal Calories Days 1 to 14 or end of treatment
Secondary Percentage of Participants Achieving at Least 80% of Daily Goal Protein Days 1 to 14 or end of treatment
Secondary Ctrough: Observed Concentration at the End of a Dosing Interval of TAK-954 Day 5 pre-dose
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness