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The Basel Enteral High Protein Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02678325
Recruitment Status : Recruiting
First Posted : February 9, 2016
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

The objective of this study is to compare the difference in daily protein intake of critically ill patients in two standardized enteral nutrition formulas (20% versus 33% percent) with the same caloric density of 1.2 kcal/ml.

The total amount of protein taken in on day four after starting the early enteral feeding is defined as primary endpoint.


Condition or disease Intervention/treatment Phase
High Enteral Protein Nutrition Muscle Breakdown Autophagy Other: Standardized high protein enteral nutrition Other: Standardized normal protein enteral nutrition Not Applicable

Detailed Description:

For years, the Surgical Intensive Care Unit of the University Hospital Basel has used an early enteral approach for the feeding of critically ill patients with different formulas that have high protein content (20% of total energy). However, the energy goal in the first week is only 20 kcal for normal-weight and 12.5 kcal for obese patients, which results in daily protein amounts of 0.8 to 1 g/kg bodyweight (BW), so that additional protein has to be administered. Due to a suggestion of the dietetic service of the University Hospital Basel, Fresenius Kabi produced a whey based enteral feeding formula for intensive care patients. Specific further adaptations for this patient group included micronutrients and a fatty acid profile as well as low fibres. Surgical Intensive Care Unit of the University Hospital Basel now are offered the opportunity to test this formula in clinical practice and hypothesize that this specific high-protein (30% of energy) enteral formula reaches the same amount of daily caloric intake with a higher total daily amount of protein and equal intestinal tolerance compared to a usual intestinal nutritional formula.

In order to test this hypothesis, investigators plan a double-blind, randomized and controlled study with the aim to achieve a target protein quantity of ≥1.3 g/kg BW with an energy target of 20kcal/kg BW per day, based on a new, specifically designed formula for critically ill patients. The amount of protein on day four after starting the early enteral feeding is defined as primary endpoint. Secondary endpoints are the total amount of calories, the nitrogen balance on day five as well as side effects like gastric residual content, diarrhoea and constipation. Inclusion criteria were an expected stay at the ICU of four days or longer on admission and 18 years of age or older Exclusion criteria consisted of BMI ≤ 18, pregnancy, intestinal perforation, mechanical intestinal obstruction, terminal state of consuming disease, severely impaired liver function and noradrenaline ≥0.5µg/kg BW/min.. On this purpose, 90 critically ill patients will get either of the two enteral feeding products as described above. In case of the event that an increased protein intake can be obtained by the protein-rich formula, an additional study will investigate the influence of early protein-rich nutrition on skeletal muscle wasting with critically ill patients.

In a pre-study investigators will administer the high protein formula to 20 patients to test tolerance and suitability for the nutritional Targets in question. Tolerance will be defined by the absence of one of the following clinical symptoms :

  • Reflux
  • Diarrhoea
  • Constipation
  • Nausea
  • Vomiting

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Tolerance of Early High Protein Nutrition of the Critically Ill: Comparison of a Protein-rich Enteral Formula With a Standardized High Carbohydrate Product on Total Calorie and Protein Intake
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Standardized normal protein enteral nutrition formula
Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 20% of the total caloric intake
Other: Standardized normal protein enteral nutrition
double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration (compared to normal enteral protein administration) on muscle breakdown and mortality.

Experimental: Standardized high protein enteral nutrition formula
Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 33% of the total caloric intake
Other: Standardized high protein enteral nutrition
A double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration on muscle breakdown and mortality.




Primary Outcome Measures :
  1. The amount of protein [ Time Frame: 4 days ]
    The amount of protein administered on day four after starting the early enteral feeding.


Secondary Outcome Measures :
  1. The total amount of calories [ Time Frame: 4 days ]
    Indirect Calorimetry

  2. The nitrogen balance on day four [ Time Frame: 4 days ]
    Nitrogen input - nitrogen loss measured over 4 days

  3. Gastric residual Content in ml [ Time Frame: 4 days ]
    ml

  4. Number of diarrhea events [ Time Frame: 4 days ]
    Number

  5. occurence of constipation as measured in time without defecation [ Time Frame: 4 days ]
    time frame without defecation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age 18 years or older)
  • expected stay at the ICU of four days upon admittance or longer
  • expected enteral feeding during at least four days.

Exclusion Criteria:

  • BMI ≤ 18
  • Mechanical intestinal obstruction
  • Intestinal perforation
  • Severely impaired liver function
  • Terminal state of consuming disease
  • Noradrenaline ≥0.5µg/kg BW/min
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02678325


Contacts
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Contact: Martin Siegemund, Prof. Dr. MD +41 (0)61 328 64 14 martin.siegemund@usb.ch
Contact: Alexa Hollinger, Dr. med. +41 (0)61 328 65 08 alexa.hollinger@usb.ch

Locations
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Switzerland
University Hospital Basel Recruiting
Basel, Switzerland, 4031
Contact: Martin Siegemund, MD    +41613286414    martin.siegemund@usb.ch   
Contact: Alexa Hollinger, MD    +41613286508    alexa.hollinger@usb.ch   
Sub-Investigator: Lukas Gantner, MD         
Sub-Investigator: Katrin Ledergerber, MD candidate         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Director: Martin Siegemund, Prof. Dr. MD Deputy Chief Physician, Surgical Intensive Care Unit, University Hospital Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02678325    
Other Study ID Numbers: 2016-00041
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No