An interventional study of Peptamen Bariatric and Replete in Critically Ill Mechanically Ventilated Subjects, sponsored by Société des Produits Nestlé (SPN). Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-26.
Sponsored by Société des Produits Nestlé (SPN) · Not applicable, Interventional, and Basic science
To compare the nutritional effect on blood glucose of two commercially available enteral diets in overweight or obese patients in the Intensive Care Unit.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 106 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Société des Produits Nestlé (SPN) is the lead sponsor of 314 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Peptamen Bariatric
Other: Peptamen Bariatric
Replete
Other: Replete
Commercially available enteral diet
Commercially available enteral diet
Glucose variability - Number of glycemic events outside the serum glucose range of 110-150 mg/dl
Number of glycemic events outside the serum glucose range of 110-150 mg/dl
Time frame: First seven days in the ICU
Glucose variability - Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl
Number of glycemic events between 80-110 mg/dl and 150-180 mg/dl
Time frame: First seven days in the ICU
Glucose variability - Number of episodes of hypoglycemia (glucose < 80 mg/dl)
Number of episodes of hypoglycemia (glucose \< 80 mg/dl)
Time frame: First seven days in the ICU
Glucose variability - Number of episodes of hyperglycemia (glucose > 180 mg/dl)
Number of episodes of hyperglycemia (glucose \> 180 mg/dl)
Time frame: First seven days in the ICU
Glucose variability - Average glucose levels
Average glucose levels
Time frame: First seven days in the ICU
Need for exogenous insulin administration
Number of administrations, amount of insulin received, number of times insulin order adjusted, circulating C-peptide at baseline, day 3, 5 and 7
Time frame: First seven days in the ICU
Need for exogenous glucose administration
Number of times of administration and amount of glucose received
Time frame: First seven days in the ICU
Nursing time
Time required to monitor glucose levels and adjust insulin regimens in subset of patients studied
Time frame: First seven days in the ICU
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Société des Produits Nestlé (SPN)