NCT07059988 Endogenous Energy Production in Critically Ill Patients
| NCT ID | NCT07059988 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska University Hospital |
| Condition | Critical Illness |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-14 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-14 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to investigate when critically ill patients transition from a non-suppressible catabolism to a normal response to feeding. Endogenous production of glucose, fat and protein will be studied on a minimum of two occasions in mechanically ventilated ICU patients, in a fasted state and during parenteral nutrition. Substrate kinetics are estimated by a tracer dilution method using infusions of isotopically labeled glucose, glycerol and phenylalanine. Blood sampling for metabolomics analysis will be performed to elucidate potential biomarkers indicating an anabolic response to nutrition.
Eligibility Criteria
Inclusion Criteria: For the ICU group: 1. ≥18 years old and admitted to the ICU 2. Invasive mechanical ventilation 3. Arterial and central line in situ 4. Expected to remain in ICU \>72 hours For the control group: 1\. ≥18 years old Exclusion Criteria: 1. Lack of informed consent by patient/next of kin 2. Liver transplant 3. Acute or acute on chronic liver failure 4. Cirrhosis 5. Known diabetes mellitus 6. Pancreatic surgery 7. Acute or chronic pancreatitis 8. Pregnancy 9. Intubated only for airway protection or neurologic deficit 10. Mitochondrial disease 11. Disorder of amino acid metabolism 12. Familial hypertriglyceridemia 13. Severe acquired hypertriglyceridemia (≥10 mmol/L) 14. Requiring treatment of hypoglycemia in the last 72 hours before inclusion. 15. Requiring ongoing large volume resuscitation of crystalloids or blood products 16. \>72 hours in ICU before enrollment 17. Readmission to ICU within 1 week of ICU discharge. 18. Morbidly obese (BMI ≥35) 19. Limitations of treatment to best supportive care 20. Ongoing treatment with insulin/glucose related to hyperkalemia
Contact & Investigator
Olav Rooyackers, PhD
STUDY CHAIR
Karolinska University Hospital/Karolinska Institute
Frequently Asked Questions
Who can join the NCT07059988 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Illness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059988 currently recruiting?
Yes, NCT07059988 is actively recruiting participants. Contact the research team at martin.sundstrom-rehal@regionstockholm.se for enrollment information.
Where is the NCT07059988 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT07059988 clinical trial?
NCT07059988 is sponsored by Karolinska University Hospital. The principal investigator is Olav Rooyackers, PhD at Karolinska University Hospital/Karolinska Institute. The trial plans to enroll 40 participants.