EUCTR2021-002329-56-ES
Active, not recruiting
Phase 1
Exploratory study to evaluate the efficacy and safety of nutritionally administering 1.5 g protein/kg/day vs. 1.0 g protein/kg/day in the catabolic phase of the critically ill patient on mechanical ventilation. - efficacy and safety of administering elevated levels of prOteins to critically ill patients prOteins
Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)0 sites200 target enrollmentJune 25, 2021
ConditionsAcquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.MedDRA version: 20.0Level: PTClassification code 10077255Term: Intensive care unit acquired weaknessSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Not possible to specify
DrugsSmofKaviben Central
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acquired Weakness in the Intensive Care Unit (DAUCI) of the critically ill patient.
- Sponsor
- Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must meet all criteria for inclusion:
- •1\. Critically ill patient, adult \> 18 years of age.
- •2\. Admission to the ICU during the previous 48 hours.
- •3\.Patients on invasive mechanical ventilation with a minimum expected duration of \> 3 days.
- •4\.Patient with a minimum expected duration of clinical nutrition of \> 7 days from 48 hours after admission.
- •5\.Written informed consent from the patient or the patient's legal representative or deferred written consent from the patient or the patient's legal representative.
- •6\.Central venous access available for continuous infusion of study drugs.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Refusal of informed consent
- •2\. Acute renal failure (renal injury stage of 3\)
- •3\.Hepatic failure (cirrhosis or Chilg\-Pugh Scale \> 5\).
- •4\.Severe hepatic insufficiency with INR \> 1\.7 (prothrombin time \< 50%) and encephalopathy.
- •5\.Patients with COVID\-19
- •6\.Body Mass Index (BMI) \> 40 or \< 18\.5 (morbid obesity or previous caloric malnutrition)
- •7\.Pregnant patients
- •8\.CNS pathologies (Glasgow \< 6\)
- •9\.Peripheral SN pathologies
- •10\.Patients with cognitive dysfunction/dementia or unable to follow instructions regarding MRC tests.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Exploratory study to evaluate the efficacy and safety of tocilizumab for Takayasu's arteritis based on classification by type of autoantibodyJPRN-jRCTs021210077Ishii Tomonori20
Recruiting
Phase 2
Exploratory Study to Evaluate the Efficacy and Safety of Baricitinib in Interstitial Pneumonia Associated with Anti-MDA5 Antibody-Positive DermatomyositisInterstitial pneumonia associated with anti-MDA5 antibody-positive dermatomyositisJPRN-jRCTs031220641Fujio Keishi5
Not yet recruiting
Not Applicable
The exploratory study for the efficacy and the safety of Rikkunshito on symptoms of indigestion in the patients with Functional HeartburFunctional HeartburnJPRN-UMIN000029668ippon Medical School Graduate School of Medicine20
Completed
Not Applicable
The exploratory study for the efficacy and the safety of Hangeshashinto on symptoms of heartburn /belch in the patients with gastroesophageal reflux disease (GERD)GERDJPRN-UMIN000021251Osaka Medical College80
Completed
Not Applicable
The exploratory study for the efficacy and the safety of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.Abdominal pain and abdominal fullness feeling in the patients with fecal incontinenceJPRN-UMIN000030252Medical Corporation Seiaikai, Gion Usshita Hospital50