Status:
COMPLETED
Cholecalciferol Supplementation for Sepsis in the ICU
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Hypovitaminosis D
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Sepsis in a clinical entity that occurs in patients with serious infections. Though the severity of illness may vary, every year, approximately 1.6 million Americans are treated for sepsis. Even with ...
Detailed Description
Sepsis is a clinical syndrome that complicates severe infections. It is characterized by the cardinal signs of inflammation (e.g. vasodilation, leukocytosis, increased microvascular permeability) occu...
Eligibility Criteria
Inclusion
- English or Spanish speaking
- Within 24 hours of a suspected diagnosis of sepsis
- Meeting criteria for sepsis (defined as suspected or confirmed infection AND at least one diagnostic criteria in each of the following groupings):
- Vital signs:
- Temperature: \>38.3 Celsius (C) or \<36 Celsius (C)
- Heart rat e: \>90/min, or \>2 standard deviation above normal
- Tachypnea (\>20 breaths per minute)
- Altered mental status
- Positive fluid balance (\>20 mL/Kg over 24 hrs)
- Glucose \>140 mg/dL in the absence of diabetes mellitus
- Inflammatory markers:
- white blood cell (WBC): \>12,000 or \<4,000
- Normal WBC count with \>10% immature forms
- c-reactive protein (CRP) \>2 standard deviation above normal value
- Pro- calcitonin \>2 standard deviation above normal value
- Hemodynamic
- Systolic blood pressure (SBP) \<90 millimeters mercury (mmHg), Mean Arterial Pressure (MAP) \<70mmHg or SBP decrease \>40mmHg
- Vasopressor therapy to maintain MAP \>65mmHg
- Organ dysfunction
- Arterial hypoxemia arterial oxygen partial pressure/fractional inspired oxygen (PaO2/FiO2) \<300
- Acute Oliguria (UoP \<0.5 mL/Kg/hr for at least 2 hours)
- Cr increase \>0.5 mg/dL
- Coagulopathy: internationals normalized ratio (INR) \>1.5 or a-partial prothrombin time (aPTT) \>60 sec
- Thrombocytopenia: Platelet (PLT) \<100 thousand (K)
- Hyperbilirubinemia: Total Bilirubin (Tbili) \>4 mg/dL
- Tissue perfusion
- Lactate \>2 mmol/L
- Decrease cap refill or mottling
Exclusion
- Pregnant females or immediate post-partum status
- "Comfort measures only" status
- Inability to provide informed consent or have a surrogate consent
- History of renal stones within the past year
- History of hypercalcemia within the past year
- Baseline serum total calcium \>10 mg/dL
- Established diagnosis associated with increased risk of hypercalcemia (e.g. metastatic cancer, sarcoidosis, multiple myeloma, primary hyperparathyroidism)
- History of severe anemia (Hematocrit \<25%)
- Medications that affect vitamin D metabolism (e.g. antiepileptics, tuberculosis medication
- Already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01896544
Start Date
January 1 2014
End Date
December 1 2014
Last Update
June 13 2016
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114