Acute Respiratory Distress Syndrome Clinical Trial
— LOVIT ARDSOfficial title:
A Multicentre Concealed-Allocation Parallel-Group Blinded Randomized Controlled Trial to Ascertain the Effect of High-Dose Intravenous Vitamin C Compared to Placebo on Mortality or Persistent Organ Dysfunction at 28 Days in Septic Intensive Care Unit Patients
The primary objective of the study aims to compare the effect of high-dose intravenous vitamin C vs. placebo on a composite of death or persistent organ dysfunction - defined as continued dependency on mechanical ventilation, new renal replacement therapy, or vasopressors - assessed at 28 days on intensive care unit (ICU) patients. As secondary objectives, the study aims: - To compare the effect of high-dose intravenous vitamin C vs. placebo on: 1. 6-month mortality; 2. 6-month HRQoL; 3. organ function (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU); 4. global tissue dysoxia (at baseline); 5. oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) (days 1, 2, 3, 4, 7, 10, 14, and 28 if in ICU, and if still intubated); 6. occurrence of stage 3 acute kidney injury as defined by KDIGO (Kidney Disease: Improving Global Outcomes) criteria20; 7. acute hemolysis as defined by: - clinician judgment of hemolysis, as recorded in the chart, or - hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: - reticulocyte count >2 times upper limit of normal at clinical site lab; - haptoglobin < lower limit of normal at clinical site lab; - indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; - lactate dehydrogenase (LDH) >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells; 8. hypoglycemia as defined as core lab-validated glucose levels of less than < 3.8 mmol/L. - To assess baseline vitamin C levels in study participants (before the first dose of investigational product).
Status | Recruiting |
Enrollment | 800 |
Est. completion date | July 2024 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients =18 years; - Admitted to ICU with proven or suspected infection as the main diagnosis; - Currently treated with a continuous intravenous infusion of vasopressors (norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine); - Presenting with Acute Respiratory Distress Syndrome - Patient who has signed an informed and written consent, whenever he/she is capable of consent, if not ascent from his/her representant whenever he/she is present at time of screening for inclusion - Affiliation to a social security system or to an universal health coverage (Couverture Maladie Universelle, CMU). - Patients under guardianship or curatorship will be included. - Patients in case of simple emergency (legal definition) will be included. Exclusion Criteria: - > 24 hours of intensive care unit (ICU) admission; - Known Glucose-6-phosphate dehydrogenase (G6PD) deficiency; - Pregnancy; - Known allergy to vitamin C; - Known kidney stones within the past 1 year; - Received any intravenous vitamin C during this hospitalization unless incorporated in parenteral nutrition; - Expected death or withdrawal of life-sustaining treatments within 48 hours; - Previously enrolled in this study; - Previously enrolled in a trial for which co-enrolment is not allowed (co-enrolment to be determined case by case). |
Country | Name | City | State |
---|---|---|---|
France | Department Intensive Care Unit, Hospital Raymond Poincaré - APHP | Garches |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of deceased participants or with persistent organ dysfunction | Defined as death or persistent organ dysfunction: continued dependency on mechanical ventilation, renal replacement therapy, or vasopressors. | Both assessed at 28 days | |
Secondary | Vital statue at 6 months | Mortality at 6 months | at 6 months | |
Secondary | Quality of life assessement: EQ-5D-5L | Quality of life of patients will be assessed by the questionnaire EQ-5D-5L.
The questionnaire EQ-5D-5L essentially consists of 2 pages: - page1: the EQ-5D-5L descriptive system: The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box (1-digit number) next to the most appropriate statement in each of the five dimensions. - page 2: the EQ visual analogue scale (VAS): the EQ VAS records the patient's self-rated health on a vertical visual analogue scale. The 2 parts of the questionnaire can not be assessed seperately. |
at 6 months | |
Secondary | Daily organ function | Daily organ function (SOFA score days 1, 2, 3, 4, 7, 10, 14, and 28); | Days 1, 2, 3, 4, 7, 10, 14, 28 | |
Secondary | Global tissue dysoxia | Global tissue dysoxia: assessed by serum lactate concentration | At baseline and days 1, 3, 7 | |
Secondary | Occurrence of stage 3 acute kidney injury | Occurrence of stage 3 acute kidney injury as defined by KDIGO criteria | Up to day 28 | |
Secondary | Acute hemolysis | Acute hemolysis as defined by:
clinician judgment of hemolysis, as recorded in the chart, OR hemoglobin drop of at least 25 g/L within 24 hours of a dose of investigational product PLUS 2 of the following: reticulocyte count >2 times upper limit of normal at clinical site lab; haptoglobin < lower limit of normal at clinical site lab; indirect (unconjugated) bilirubin >2 times upper limit of normal at clinical site lab; LDH >2 times upper limit of normal at clinical site lab. Severe hemolysis: - hemoglobin < 75 g/L AND at least 2 of the above criteria AND requires 2 units of packed red blood cells. |
Up to day 28 | |
Secondary | Hypoglycemia | Hypoglycemia as defined by core lab-validated glucose levels of less than < 3.8 mmol/L. | During the time participants receive the 16 doses of the investigational product and the 7 days following the last dose |
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