Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients

Phase 2

Completed

Conditions: brandwonden
burns

Registration Number: NL-OMON52814

Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

-partial/full thickness acute thermal burns of at least 15% TBSA
-Admission burn ICU
-Age >=18
-Written informed consent from patient or legal representative

Exclusion Criteria

-Inclusion in another interventional clinical trial
-Patients who are pregnant or lactating
-Patients expected to have fatal disease within 24 hours
-Patients with chemical burns
-Patients who are having an known history of immune system that has been
impaired by disease, such as patients with HIV and with a CD4 count of less
than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or medical treatment
with immunosuppressive effects
-Patients who have advanced chronic liver disease confirmed by a Child-Pugh C
-Patients with active haematological malignancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The safety as in number of (serious) adverse events within 30 days after<br /><br>initiation of AP treatment is the primary endpoint. Adverse events are defined<br /><br>as any unusual experience occurring to a subject during the study, whether or<br /><br>not considered related to alkaline phosphatase. This includes fever without<br /><br>suspicion, skin rash and signs of an allergic reaction (as suspected by the<br /><br>physician) will be reported.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be the daily measured inflammatory markers (e.g.<br /><br>macrophages, neutrophils, lymphocytes, cytokine levels), and daily routine<br /><br>clinical and lab parameters including heart rate, MAP, CPAP/ASB, sepsis/ septic<br /><br>shock criteria, culture proven infection, Hb, PCT, CRP, leucocytes,<br /><br>creatinine, lactate.<br /><br><br /><br>Furthermore length of stay ICU/ hospital, time to reach complete (>95%) wound<br /><br>closure, number of surgical procedures, in-hospital mortality and mortality at<br /><br>30 days. </p><br>