RecruitingPhase 2NCT05842382

Effect of High Dose Intravenous Vitamin C in Severe Pneumonia

Effect of High Dose Intravenous Vitamin C as an Adjunct in the Treatment of Patients With Severe Pneumonia in Intensive Care Unit: a Multi-center, Double-blinded, Two-arm, Placebo-controlled, Randomized Trial


Sponsor

Clinical Research Centre, Malaysia

Enrollment

484 participants

Start Date

Jan 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This trial is a multicenter, randomized, double-blind, two-arm, parallel-group, placebo-controlled trial to investigate the effect of high dose intravenous (IV) Vitamin C as an adjunct to the standard of care for patients with severe pneumonia versus placebo in ICU.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients who are aged 18 and above
  • Patients who are diagnosed with severe pneumonia
  • Patients who are mechanically ventilated

Exclusion Criteria21

  • Known allergy to Vitamin C
  • Pregnancy
  • Known history of ongoing concomitant infection
  • Participation in another clinical trial and/or receipt of investigational drugs within 4 weeks prior to enrollment
  • Moribund patient with multiorgan failure to the judgement of the treating physician, who is not expected to survive 24 hours
  • Patient who requires home oxygen therapy or mechanical ventilation, including tracheostomy or non-invasive ventilation, except for CPAP/BIPAP for sleep-disordered breathing
  • Known history of previous or current diagnosis of renal stones
  • Known diagnosis of glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Known diagnosis of hemochromatosis
  • Known diagnosis of poorly controlled chronic pulmonary disease, including:
  • Chronic obstructive pulmonary disease with oxygen therapy
  • Chronic restrictive pulmonary disease with oxygen therapy
  • Bronchial asthma on Step 5 of treatment ladder as shown in Pocket Guide for Asthma Management and Prevention
  • Lung cancer in Stage IV of disease
  • Known diagnosis of heart failure on anti-failure treatment or requiring mechanical hemodynamic support (e.g. LVAD), with recent hospitalization within 3 months (90 days) from the date of current admission.
  • Immunocompromised state
  • Known diagnosis of malignancy and ongoing chemotherapy or radiotherapy as there is evidence that antioxidant supplement before and during treatment was associated with an increased hazard of recurrence
  • Known diagnosis of malignancy who had completed chemotherapy or radiotherapy with absolute neutrophil count ≤100 cells/mm3
  • Known diagnosis of Stage 4 and above chronic kidney disease (GFR <30 ml/min/1.73m2) and end-stage renal disease on regular dialysis (including peritoneal dialysis or hemodialysis)
  • Known history of renal transplantation
  • Absence of family members or next of kin for informed consent

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Interventions

DRUGActive Ingredient

IV Vitamin C (12g/day)

DRUGPlacebo

IV dextrose 5%


Locations(3)

Hospital Sultanah Bahiyah

Alor Star, Kedah, Malaysia

Hospital Raja Perempuan Zainab II

Kota Bharu, Kelantan, Malaysia

Hospital Raja Permaisuri Bainun

Ipoh, Perak, Malaysia

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NCT05842382


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