Critical Illness Clinical Trial
Official title:
A Phase 2b, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous TAK-954 in Critically Ill Patients With Enteral Feeding Intolerance
Verified date | September 2019 |
Source | Takeda |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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]). |
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 |
Lead Sponsor | Collaborator |
---|---|
Millennium Pharmaceuticals, Inc. |
United States, Australia, Canada, United Kingdom,
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 |
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