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Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury (CITRIS-ALI)

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ClinicalTrials.gov Identifier: NCT02106975
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

March 27, 2014
April 8, 2014
November 24, 2017
April 2014
January 16, 2018   (Final data collection date for primary outcome measure)
  • Change in SOFA score at 96 hours as compared to baseline when compared to placebo [ Time Frame: 96 hours ]
  • C-Reactive Protein and Thrombomodulin at study hours 0, 48, 96, 168 when compared to placebo [ Time Frame: Up to hour 168 ]
Same as current
Complete list of historical versions of study NCT02106975 on ClinicalTrials.gov Archive Site
  • Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at study hour 0, 48, 96, 168 if still intubated in ascorbate infused patient compared to placebo. [ Time Frame: Up to hour 168 ]
  • VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at study hour 0, 48, 96, 168 if still intubated, in ascorbate infused patient compared to placebo [ Time Frame: Up to hour 168 ]
  • SOFA scores at hours 48, 96, 168 [ Time Frame: Up to hour 168 ]
  • Ascorbate level at hour 0, 48, 96, 168 [ Time Frame: Up to hour 168 ]
  • Ventilator Free Days to day 28 [ Time Frame: Up to Day 28 ]
  • ICU-free days at day 28 [ Time Frame: Up to Day 28 ]
  • All cause mortality to day 28 [ Time Frame: Up to Day 28 ]
  • Hospital-free days at day 60 [ Time Frame: Up to Day 60 ]
  • Procalcitonin at study hour 0, 48, 96, 168 [ Time Frame: Up to hour 168 ]
  • Receptor for Advanced Glycation Endpoints at study hour 0, 48, 96, 168 [ Time Frame: Up to hour 168 ]
  • Tissue factor pathway inhibitor at study hour 0, 48, 96, 168 [ Time Frame: Up to hour 168 ]
  • SOFA Score Component at hours 48,96, 168: PaO2/FiO2 [ Time Frame: Up to hour 168 ]
  • SOFA Score Components at hours 48,96, 168: SpO2/FiO2 [ Time Frame: Up to hour 168 ]
  • SOFA Score Components at hours 48,96, 168: Platelets [ Time Frame: Up to hour 168 ]
  • SOFA Score Components at hours 48,96, 168: Total Bilirubin [ Time Frame: Up to hour 168 ]
  • SOFA Score Components at hours 48,96, 168: Vasopressor status [ Time Frame: Up to hour 168 ]
  • SOFA Score Components at hours 48,96, 168: GCS [ Time Frame: Up to hour 168 ]
  • SOFA Score Components at hours 48,96, 168: Creatinine or Urine Output [ Time Frame: Up to hour 168 ]
Same as current
Not Provided
Not Provided
 
Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury

Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ failure as measured by Sequential Organ Failure Assessment (SOFA) score,

Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by the oxygenation index and the VE40

Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a fibrinolytic state (Tissue Factor Pathway Inhibitor).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Lung Injury
  • Sepsis
  • Drug: Ascorbic Acid
    Intervention
    Other Name: Vitamin C
  • Drug: Placebo: 5% Dextrose in water
    Placebo
  • Active Comparator: Ascorbic Acid
    200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours
    Intervention: Drug: Ascorbic Acid
  • Placebo Comparator: 5% Dextrose in Water
    50ml every 6 hours for 96 hours
    Intervention: Drug: Placebo: 5% Dextrose in water
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
170
January 16, 2018
January 16, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have suspected or proven infection, and meet 2 out of 4 of the criteria for Systemic Inflammatory Response (SIRS) due to infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).
  • Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system, see Appendix A).
  • The presence of a systemic inflammatory response: Defined as: fever: >38ºC (any route) or hypothermia: <36ºC (core temp only), tachycardia: heart rate > 90 beats/min or receiving medications that slow heart rate or paced rhythm, leukocytosis: >12,000 WBC/µL or leukopenia: <4,000 WBC/µL or >10% band forms. Respiratory rate > 20 breaths per minute or PaCO2 < 32 or invasive mechanical ventilation.
  • The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection)
  • Sepsis associated hypotension (systolic blood pressure (SBP) < 90 mm Hg or an SBP decrease > 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/> 5mcg, phenylephrine, vasopressin)
  • Arterial hypoxemia (PaO2/FiO2 < 300) or supplemental O2 > 6LPM.
  • Lactate > upper limits of normal laboratory results
  • Urine output < 0.5 ml/kg/hour for > two hours despite adequate fluid resuscitation
  • Platelet count < 100,000 per mcL
  • Coagulopathy (INR > 1.5)
  • Bilirubin > 2 mg/dL
  • Glasgow Coma Scale < 11 or a positive CAM ICU score
  • ARDS characterized by all the following criteria
  • Lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms
  • Bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules)
  • Respiratory failure not explained by heart failure or volume overload
  • Decreased arterial PaO2/FiO2 ratio ≤ 300 mm Hg
  • Minimum PEEP of 5 cmH2O (may be delivered noninvasely with CPAP to diagnose mild ARDS

Exclusion Criteria:

  • Known allergy to Vitamin C
  • inability to obtain consent;
  • age < 18 years;
  • No indwelling venous or arterial catheter in patients requiring insulin in a manner that requires glucose being checked more than twice daily (e.g. continuous infusion, sliding scale);
  • presence of diabetic ketoacidosis;
  • more than 48 hrs since meeting ARDS criteria;
  • patient or surrogate or physician not committed to full support (not excluded if patient would receive all supportive care except for cardiac resuscitation);
  • pregnancy or breast feeding,
  • moribund patient not expected to survive 24 hours;
  • home mechanical ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing;
  • home O2 > 2LPM, except for with CPAP/BIPAP
  • diffuse alveolar hemorrhage (vasculitis);
  • interstitial lung disease requiring continuous home oxygen therapy;
  • Active kidney stone
  • Non English speaking;
  • Ward of the state (inmate, other)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02106975
HM20000917
1UM1HL116885-01 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Virginia Commonwealth University
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Alpha B. Fowler, MD Virginia Commonwealth University
Virginia Commonwealth University
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP