A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients
Principal Investigator: Robert Martindale, MD
What is the TOP-UP study?
The purpose of this study is to examine the effect of giving additional nutrition through an intravenous (IV) line inserted into the arm (called parenteral nutrition or PE) compares with the standard of care nutrition in critically underweight and overweight patients. Another purpose of this study is to understand if a larger study of this patient population is possible.
Who will be included?
Any critically ill patients in the ICU who are receiving nutrition through a feeding tube and mechanical ventilation will be eligible.
What is involved?
All patients will be scheduled to receive standard nutrition through a feeding tube into their stomach (enteral nutrition or EN) whether or not they are participating in the study. Patients who are enrolled into the study will be placed into one of two treatment groups (listed below). Half of the participants will be randomized (like flipping a coin) to the experimental group and half to the control group.
Experimental Group (supplemental nutrition): Patients in this group will also be given a nutrition supplement through an intravenous (IV) line inserted in their arm. The supplemental IV nutrition is a mixture of amino acids (proteins), fat, and sugar. Amino acids are one of the building blocks for proteins and play an important role in the body’s essential functions. The sugars and fat are the chief source of energy in the body. The supplemental IV nutrition will be given to them in addition to the enteral nutrition to provide added calories and protein.
Control Group (regular nutrition): Patients in this group will not receive any supplemental nutrition through an intravenous (IV) line for at least the first 7 days of the study.
If patients receive the supplemental IV nutrition, they will get the supplemental nutrition for at least 7 days during their stay in the ICU. If they leave the ICU before 7 days, the IV treatment will continue until day 8 or until they are able to eat enough food by mouth. Feeding through the stomach (enteral nutrition) will be stopped when their feeding tube comes out.
If patients (or their family’s) agree to participate in this study, study staff members will collect and store information about them in a secured database. This information will be about their general health, medical history, reason for being admitted into the ICU, and nutritional status. Patients will also be asked questions about their quality of life and health status as part of this study. They will be asked these questions at the beginning of the study, when they are discharged from the hospital, and 3 months and 6 months after they were admitted into the ICU. For the 3 month and 6 month follow-up assessments, we will call the patients and ask them these questions over the phone.
During the time patients are given enteral and/or supplemental nutrition as part of this study, we will collect data about how well they comply with taking the nutrition and whether there are any interruptions in the nutrition being given.
In order to measure physical strength, patients will be asked to take part in activities to see about the strength of their muscles while they are in the hospital. To do this, we will ask them to do a 6-minute walk test just prior to when they are discharged from the hospital, if they agree and are able to. This test measures how far they can walk in 6 minutes.
We will also ask that patients complete a hand grip test when you are discharged from the ICU and from the hospital. This test measures how hard they can grip. Patients will have to hold a small device in their hand and grip the device three times in a row for 5 seconds each. We will measure the pressure of their grip in pounds and record this information.
The femoral ultrasounds are done to assess the muscle layer thickness. These ultrasounds will be done at or around admission into the hospital, and then each week patients are admitted for up to 4 weeks. This ultrasound requires that they lay flat in their bed so that technician may put gel on their thigh and move the ultrasound probe along their thigh for up to 20 minutes to take measurements.