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Tyrosine

Clinical trials investigating Tyrosine are being used in studies of nutrition support after major surgery. These trials look at outcomes such as muscle loss and infection risk in adult patients after oesophagectomy or major emergency abdominal surgery.

Table of Contents

Clinical trials overview

Two authorised interventional trials are investigating Tyrosine in the setting of nutrition support after major surgery.[1][2] Both studies are Phase 3 trials, which means they are testing the study treatments in larger patient groups to compare outcomes.[1][2]

The trials focus on adult surgical patients, especially people recovering from oesophagectomy and major emergency abdominal surgery.[1][2] The research is centered on recovery problems such as muscle loss and infection during the hospital stay.[1][2]

Trial after oesophagectomy

The first trial is titled “Route of nutrition and muscle wasting after oesophagectomy.”[1] It is a Phase 3 interventional study with 38 participants and is marked as authorised.[1]

This study is looking at how the route of nutrition affects cachexia, which is severe weight and muscle loss linked to illness.[1] The intervention listed is SmofKabiven emulsion for infusion, given by parenteral use, meaning nutrition delivered through a vein.[1]

The main condition studied is oesophagectomy, an operation on the esophagus.[1] The trial summary says the goal is to understand how nutrition route impacts muscle wasting after this surgery.[1]

Trial after major emergency abdominal surgery

The second trial is titled “Early versus postponed supplementary parenteral nutrition after major emergency abdominal surgery.”[2] It is also a Phase 3 interventional study and is authorised, with 342 participants planned.[2]

This study compares early and postponed supplementary parenteral nutrition, which means extra nutrition given through a vein either sooner or later after surgery.[2] The interventions listed are SmofKabiven Perifer and SmofKabiven, both given by infusion.[2]

The condition studied is major emergency abdominal surgery, and the summary says the trial is testing whether timing of nutrition can lower the risk of nosocomial infection, meaning infection acquired in the hospital.[2]

Study design, phase, and participation

Both trials are interventional, so researchers are assigning a study nutrition plan and then measuring the results.[1][2] This is different from an observational study, where researchers only watch what happens without assigning treatment.

Both studies are in Phase 3, which usually means the treatment strategy is being tested in a larger group and compared with another approach.[1][2] The trial data does not provide detailed inclusion or exclusion rules, so only the main target populations can be identified from the source information.[1][2]

The first trial plans to include 38 patients, while the second plans to include 342 patients.[1][2] These numbers help show the scale of each study and how many people researchers want to observe.

Main outcomes being measured

The primary outcome is the main result the researchers want to measure.

In the oesophagectomy trial, the primary outcome is the mean difference in muscle size on CT scan from before surgery to 10 days after surgery.[1] This tells researchers whether the nutrition approach may help reduce muscle loss after the operation.[1]

In the emergency abdominal surgery trial, the primary outcome is the reduction in the rate of infectious complications during admission.[2] This means the researchers want to know whether one timing strategy for nutrition leads to fewer hospital infections.[2]

What these studies may mean for patients

These trials are not general drug studies; they are focused on nutrition support after serious surgery.[1][2] The patient groups are people recovering from major operations, where muscle loss and infection are important recovery problems.[1][2]

For patients, the key question in these studies is whether the timing or route of nutrition can improve recovery outcomes.[1][2] The trials are designed to provide evidence on which nutrition approach may better protect muscle size or reduce infections after surgery.[1][2]

Trial ID Phase Condition studied Status Enrollment
2023-507649-27-00 Phase 3 Oesophagectomy Authorised 38
2023-505378-14-00 Phase 3 Major emergency abdominal surgery Authorised 342

FAQ

  • What are the Tyrosine clinical trials studying? The trials are studying how different nutrition routes affect recovery after major surgery. One trial looks at muscle wasting after oesophagectomy, and the other looks at infection risk after emergency abdominal surgery.
  • Who can take part in these trials? The target groups are adults who have had oesophagectomy or major emergency abdominal surgery. The trial data does not list more detailed participation rules.
  • What phase are the Tyrosine trials in? Both trials are Phase 3 studies. Phase 3 trials usually compare treatments in larger groups to see how well they work in real patient care.
  • What results are the trials measuring? One trial measures muscle size change on CT scan from before surgery to 10 days after surgery. The other measures the rate of infectious complications during the hospital stay.
  • Are these Tyrosine trials treatment studies or observation studies? They are interventional studies, which means the researchers are giving a study treatment and comparing results. The trials are testing nutrition support approaches after surgery.

Ongoing Clinical Trials on Tyrosine

  • Study on Nutrition Methods and Muscle Loss After Esophagectomy Using SmofKabiven and Drug Combination for Patients Recovering from Esophageal Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

  • Study on Early vs. Delayed Supplementary Parenteral Nutrition with SmofKabiven for Patients After Major Emergency Abdominal Surgery

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Interventional study: A study where researchers give a treatment or care plan and then measure the results.
  • Phase 3: A later stage of clinical research that usually compares treatments in larger groups of patients.
  • Oesophagectomy: An operation to remove part or all of the esophagus, the tube that carries food from the mouth to the stomach.
  • Major emergency abdominal surgery: Large urgent surgery in the belly area, often done because of a serious medical problem.
  • Parenteral nutrition: Nutrition given through a vein instead of by mouth or through the stomach.
  • Supplementary parenteral nutrition: Extra nutrition given through a vein when regular feeding is not enough.
  • Infusion: A treatment given slowly through a vein over time.
  • Muscle wasting: Loss of muscle size or muscle bulk, often seen after serious illness or surgery.
  • Cachexia: A severe condition with weight and muscle loss linked to illness.
  • CT-scan: A special imaging test that creates detailed pictures inside the body.
  • Infectious complications: Health problems caused by infection after treatment or surgery.
  • Nosocomial infection: An infection acquired in the hospital.

References

  1. https://clinicaltrials.gov/study/2023-507649-27-00
  2. https://clinicaltrials.gov/study/2023-505378-14-00