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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03884036
Other study ID # 2019-003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 18, 2019
Est. completion date October 2019

Study information

Verified date August 2019
Source Hangang Sacred Heart Hospital
Contact Hee Yeong Kim, MD
Phone 82-2-2639-5650
Email kimhy@hallym.or.kr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.


Description:

Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications.

The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.


Recruitment information / eligibility

Status Recruiting
Enrollment 264
Est. completion date October 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- vitamin D <30 ng/ml

- patients undergoing burn surgery

Exclusion Criteria:

- age < 18 years old

- hypercalcemia

- renal disease

- cardiac disease ( EF<40%, MI, angina)

- respiratory disease (ARDS, pneumonia)

- intubated patients

- electrical burn

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Vitamin D
Vitamine D

Locations

Country Name City State
Korea, Republic of Hangang Sacred Heart Hospital Seoul

Sponsors (2)

Lead Sponsor Collaborator
Hangang Sacred Heart Hospital Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Hospital stay Length of hospital stay Time from operation to discharge (approximately within 1 month)
Primary Incidence of postoperative complications Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death Within postoperative 1 month
Secondary Vitamin D level Serum 25-hydroxy vitamin D level Within postoperative 14 days
See also
  Status Clinical Trial Phase
Terminated NCT00974597 - Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery N/A
Recruiting NCT03590873 - The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients N/A
Not yet recruiting NCT05241912 - Supernormal Oxygen Delivery for Patients With Severe Burns Early Phase 1