Shock
Conditions
Keywords
hypovolemic or septic
Brief summary
The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.
Detailed description
It has been shown that the stress that occurs during trauma, infection and/or shock depletes many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to further complications. The purpose of this study is to determine the effectiveness of high doses of Vitamin C in critically ill patients.
Interventions
DRUGAscorbic Acid
66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
OTHERRingers Lactate or Normal Saline
Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Activation of the Mass Transfusion Protocol following surgery or trauma. * Diagnosis of septic shock. Septic shock will be defined as sepsis induced hypotension (i.e. systolic blood pressure \<90mmHg or drop of systolic blood pressure \>40mmHg in the presence of infection) that does not respond to a 2 liter fluid bolus.
Exclusion criteria
* Age less than 18 years. * Pregnant women. * Creatinine of greater than 2.2 g/dl at time of enrollment, history of chronic kidney or end stage renal disease, rise in creatinine \> 1 g/dl within 24 hours prior to enrollment. * Brain death diagnosed within 4 hours of presentation to the trauma bay or intensive care unit * Patients with history of hemolytic blood disease, e.g. glucose-6-phosphate dehydrogenase deficiency, Sickle Cell Disease and Thalassemia. * Patients in isolated cardiogenic shock. * History of liver cirrhosis * Transplant patients (liver, kidney, heart)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of High Dose Vitamin C Therapy in Shock Patients | 30 days | Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ascorbic Acid Ascorbic Acid
Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams | 7 |
| Ringers Lactate or Normal Saline Ringers Lactate or Normal Saline
Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour. | 4 |
| Total | 11 |
Baseline characteristics
| Characteristic | Ascorbic Acid | Ringers Lactate or Normal Saline | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 3 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment United States | 7 participants | 4 participants | 11 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Primary
Efficacy of High Dose Vitamin C Therapy in Shock Patients
Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.
Time frame: 30 days
Population: Study terminated prior to data collection completion. No data analysis performed.