An interventional study of amino acid tracer injection for metabolism analysis in Metabolism and Nutrition Disorder, sponsored by Rabin Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Rabin Medical Center · Not applicable, Interventional, and Diagnostic
Introduction Sarcopenia is defined as progressive generalized loss of skeletal muscle mass, strength and function. Sarcopenia due to lack of physical activity is a known phenomenon and is usually observed as a normal part of aging or in certain diseases and pathogenic processes. Major associated factors causing development of sarcopenia may be summarized as interactions of environmental and hormonal factors, underlying diseases, activation of inflammatory pathways, mitochondrial dysfunction, reduced satellite cell numbers, and loss of neuromuscular junctions.
Intensive care acquired weakness (ICU-AW) known formerly as critical illness polyneuropathy, is a diagnosis that becomes more common as survival rates from long ICU hospitalization are more prevalent. It is characterized by a primary axonal degeneration, without demyelination, that typically affects motor nerves more than sensory nerves.
ICU-AW affects the limbs (particularly the lower extremities) in a symmetric pattern. Weakness is most notable in proximal neuromuscular areas (e.g., the shoulders and hip girdle). In addition, involvement of the respiratory muscles can occur and can impede weaning from mechanical ventilation.
The pathophysiological mechanisms of ICU-acquired weakness are believed to be multifactorial. Some suspected factors include dysfunctional microcirculation and hyperglycemia. It has been shown that tight glucose control in ICU patients reduces the risk for ICU-AW (although it has been associated with other adverse events). Sodium channels channelopathy is also a researched cause for ICU-AW. Muscle loss in the ICU are usually related to bedridden condition and lack of mobility, increase in ubiquitination and inadequate protein administration associated with large negative nitrogen balance. In addition mechanical ventilation contributes greatly to this problem. This has been particularly relevant in post trauma/surgical long stayer patients.
In the past years great progress was made in the investigation of protein balance, breakdown and synthesis using stable isotope tracers in various medical conditions. In a research performed in PICU (1-5) and ICU (6, 7) regarding the measurement of plasma amino acid during critical illness, stable phenylalanine, tyrosine leucine, arginine and citrulline isotope were used intravenously without any safety issue problem. Another study was performed on adults suffering from COPD with matched healthy adults, using stable isotopes of phenylalanine, tyrosine leucine, isoleucine and valine (8). During the study the isotopes were given parenterally as well as enterally. The study showed significant change in splanchnic extraction of various amino acids and higher turnover of BCAA in COPD patients. Using the theory that supplemental milk can compensate for the elevated turnover of BCAA in COPD patients, using the isotope analysis demonstrated that this theory was proven wrong and the conclusion was that alterations are present in BCAA metabolism despite normal plasma levels in normal weight COPD. Further research is needed to find a way to compensate for it. These studies and other recent studies (9-19) show us the safety regarding the use of stable isotope tracers whether IV or PO, while giving us the opportunity to assess the metabolism of amino acid in all sorts of pathological states.
Hypothesis \& Aim of the study We think that based on current literature, there are important differences between critically ill patients and healthy population in the amino acid profile and distribution in the body as well as synthesis and breakdown.
The aim of the study is to measure these differences in long ICU stayers (above 7 days) admitted in the ICU after surgical/trauma injury, and to try and help aiming future treatment and research in this field.
Study population:
Control group:
Exclusion Criteria:
amino acid tracer injection for metabolism analysis The dose needed to be injected from the tracer element in the beginning of the study is a bolus of 16ml Amino acid tracer (non-radioactive). it is a single bolus, no other elements or drug will be administered.
Other: amino acid tracer injection for metabolism analysis
amino acid tracer injection for metabolism analysis The dose needed to be injected from the tracer element in the beginning of the study is a bolus of 16ml Amino acid tracer (non-radioactive) it is a single bolus, no other elements or drug will be administered.
Other: amino acid tracer injection for metabolism analysis
the intervention includes injecting stable amino acid tracers in order to evaluate differences in processing of amino acid in critically ill patients compared to a normal population. after injection 5 ml of blood will be drawn at time 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes from the start of the study, a total of 14 blood samples (70 cc).
The amount of each amino acid will be measured in mmol/liter
In the study stable isotopes of amino acids will be injected, and afterward the amount of each amino acid will be checked in order to assess degradation and metabolism. Composite measure.
Time frame: during 3 hours from injection
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rabin Medical Center