High Dose Intravenous Ascorbic Acid in Severe Sepsis

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Sepsis

In brief

Despite an organized treatment approach outlined in expert-consensus guidelines for sepsis with fluid resuscitation to treat hypovolemia, antibiotics to target the infectious insult, and vasopressors for hypotension, mortality rates for sepsis remain high and the incidence continues to rise, making sepsis the most expensive inpatient disease. 1. Recent research has described the therapeutic benefits associated with ascorbic acid treatment for sepsis. 2. Researchers objectives are to perform a randomized-controlled clinical trial investigating the ability of ascorbic acid(vitamin C) administration to decrease organ dysfunction in severe sepsis. The widespread occurrence of microvascular dysfunction in sepsis leading to tissue hypoxia, mitochondrial dysfunction, and adenosine triphosphate (ATP) depletion, gives rise to organ failure. 3. Patients with organ failure and sepsis (severe sepsis) are at a higher risk of death than patients with organ failure alone. Critically ill patients may have an increased requirement for ascorbic acid in sepsis and these patients frequently have levels below normal. Ascorbic acid administration, has been shown to correlate inversely with organ failure (human literature) and directly with survival (animal studies). 4,5 Intravenous ascorbic acid therapy decreases organ failure by providing a protective effect on several microvascular functions including improving capillary blood flow, decreasing microvascular permeability, and improving arteriolar responsiveness to vasoconstrictors. Defining the utility of novel agents to augment researchers care for severe sepsis is an important task as investigators continue the institutional focus on sepsis care.

Key facts

Study ID: NCT02734147
Run by: Christiana Care Health Services
People needed: 24
Starts: 2016-04-01
Expected to finish: 2017-11-23
Last updated by the study team: 2021-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with:
A suspected or confirmed infection with an order for intravenous antibiotics or antivirals
The presence of acute sepsis-induced organ dysfunction
Definition of organ dysfunction:
Arterial hypoxemia [PaO2 /FiO2 < 300]
Hypotension [systolic blood pressure (SBP) < 90 mmHg or SBP decrease > 40 mmHg]
Lactic acidosis [lactate > 2.5 mmol/L]
Acute kidney injury [creatinine >2.0 or urine output < 0.5 ml/kg/hr for >2 hours despite fluid resuscitation]
Thrombocytopenia [platelet count < 100,000]
Acute coagulopathy [international normalized ratio (INR) > 1.5]
Hepatic failure [bilirubin > 2 mg/dL].
Predisposition, Infection, Response, and Organ Failure (PIRO) score ≥ 10

You may not qualify if…

Age < 18 years
Pregnancy or breastfeeding
Requirement for immediate surgery within the treatment protocol timeframe
Inability to obtain written informed consent from subject or surrogate
Patient to receive comfort measures only

Where it is running

Chrisitana Care Health System-Christiana Hospital — Newark, Delaware, United States

Full record on ClinicalTrials.gov

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