Serum Tryptase Levels During Cardiac Surgery, Diagnosis and Treatment Decisions for Allergic Reactions
Study Details
Study Description
Brief Summary
The investigators aim to assess tryptase test efficacy for measuring the allergic response to protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a differential diagnosis on the basis of potential allergens or clinical causes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Venous blood samples from cardiac surgery cases will be obtained for tryptase measurement upon admission to the operating room (OR) and immediately prior to and 30 min after protamine infusion initiation. A rapid effect-response-based clinical assessment will be made using clinical and laboratory monitoring data for diagnosis and treatment decisions during protamine infusion, which may complicate the recovery from surgery.
Study Design
Outcome Measures
Primary Outcome Measures
- Patients number with high tryptase level (> 25 µg/L ). [30 min]
Tryptase will be measured using the ImmunoCAP Tryptase kit (Phadia, Uppsala, Sweden), and the cutoff level for elevated tryptase is >11.5 µg/L. A 25 µg/L cutoff value has been found to be highly suggestive of an İmmunoglobulin E (IgE) -mediated reaction.
Secondary Outcome Measures
- Patients number with allergic reaction involving of 1 or more organ/systems (skin, respiratory, or cardiovascular system) following the study drug infusion. In this study, mainly the cardiovascular and skin symptoms will be focused on. [30 min]
These outcomes will be determined following the Council for International Organizations of Medical Sciences (CIOMS 1999 and ) definitions for anaphylactic reactions. Additionally, (World Health Organization - Uppsala Monitoring Centre) WHO-UMC system will be used for assesment of causality categories for adverse drug reactions.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Cardiac by-pass cases
Exclusion Criteria:
-
Insulin dependent diabetes
-
Atopy
-
Drug allergy history
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mustafa Kemal University Hospital | Hatay | Turkey | 31100 |
Sponsors and Collaborators
- Mustafa Kemal University
Investigators
- Principal Investigator: Menekse Oksar, M.D., Mustafa Kemal University Medical School
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- The authors reported that elevated acute serum tryptase (>141% from baseline or absolute tryptase >15.7 mg/L) is highly predictive of IgE-mediated anaphylaxis and that these two methods of interpretation are comparable.
- Malinovsky et al. reported that tryptase concentrations were elevated in 50% of their patients, and the positive and negative predictive values (PPV and NPV) of tryptase were 100% for both tryptase >12 and >25 at the first samples.
- Krishna et al. reported sensitivities, specificities, PPV and NPV for a tryptase of >25 mcg/L to be 64, 74, 82 and 52 respectively in 103 patients which were similar to the values reported by Mertes et al.
Publications
None provided.- 2014/10