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Role of high dose vitamin D3 on anemia in mechanically ventilated patients with sepsis

Phase 3
Conditions
Health Condition 1: A419- Sepsis, unspecified organism
Registration Number
CTRI/2022/05/042836
Lead Sponsor
ICMR
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients who are mechanically ventilated with invasive ventilation

2.Patients with sepsis (defined by new onset organ dysfunction with evidence of infection)

3.Age 18 years - 80 years

4.Patients expected to receive intensive care for > 48 hours

Exclusion Criteria

1.Pregnancy and post-partum patients (till 42 days after delivery)

2.Disseminated malignancy, which is active

3.Patients already entered into any trial with intervention expected to have an effect on hemoglobin level

4.Admission to ICU within last 3 months

5.Patients having active bleeding from any source

6.Refractory shock

7.Patients having hypercalcemia (serum calcium > 10.5 mg/dl or ionized calcium levels > 5.4 mg/dl)

8.Morbid obesity (BMI > 40 kg/m2)

9.AIDS

10.Cirrhosis with varices

11.Chronic renal dysfunction requiring dialysis

12.Receipt of high-dose vitamin D3 therapy in the preceding 6 months

13.Patients not tolerating enteral feed

14.Hyperparathyroidism

15.History of allergy to Vitamin D3 or one of the excipients in the medications

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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