High Dose Intravenous Ascorbic Acid in Severe Sepsis
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | April 2016 |
| End Date: | November 23, 2017 |
The Efficacy of Intravenous Ascorbic Acid in Patients With Severe Sepsis
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 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.
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 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.
Inclusion Criteria:
Patients with:
1. A suspected or confirmed infection with an order for intravenous antibiotics or
antivirals
2. The presence of acute sepsis-induced organ dysfunction
Definition of organ dysfunction:
1. Arterial hypoxemia [PaO2 /FiO2 < 300]
2. Hypotension [systolic blood pressure (SBP) < 90 mmHg or SBP decrease > 40 mmHg]
3. Lactic acidosis [lactate > 2.5 mmol/L]
4. Acute kidney injury [creatinine >2.0 or urine output < 0.5 ml/kg/hr for >2 hours
despite fluid resuscitation]
5. Thrombocytopenia [platelet count < 100,000]
6. Acute coagulopathy [INR > 1.5]
7. Hepatic failure [bilirubin > 2 mg/dL].
8. PIRO (Predisposition, Infection, Response, and Organ Failure) score ≥ 10
Exclusion Criteria:
1. Age < 18 years
2. Pregnancy or breastfeeding
3. Requirement for immediate surgery within the treatment protocol timeframe
4. Inability to obtain written informed consent from subject or surrogate
5. Patient to receive comfort measures only
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