Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
|First Received Date ICMJE||September 9, 2008|
|Last Updated Date||June 24, 2009|
|Start Date ICMJE||September 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Differences in hypotensive patients between the use of a tourniquet and non tourniquet sampling for Lactic Acid level. [ Time Frame: At the initial evaluation of the patient ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00750516 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet|
|Official Title ICMJE||Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet|
This study seeks to determine whether the Lactic Acid blood level in a critically ill patient must be drawn with a non-tourniquet venipuncture. The null hypothesis is that there is no significant difference in Lactic Acid blood level in critically ill patients in a sample taken from either with a tourniquet or a non-tourniquet veni-puncture.
Monitoring of Lactic acid level is helpful in both identifying potentially serious ill patients as well as identifying in the ICU patients with high morbidity and mortality.
When a patient arrives to an Emergency Department and that patient is hypotensive (BP less than or equal to 90 systolic), the nursing staff often starts an IV and if possible draws the patient's initial blood tests off that first IV site; or if the patient has had an IV started in the field by EMS, the nursing staff will draw blood from another site using a tourniquet. This initial work up by the nursing staff takes 15 -20 minutes before a physician may see the patient. Since the present standard Lactic Acid test must be drawn either by arterial puncture or venipuncture without a tourniquet, this test is rarely done as part of their (the RNs) initial blood draws.
This simple impediment of needing to repeat the venipuncture without a tourniquet, especially in patients who often have venous access difficulty, delays the identification of appropriate patients for early and aggressive management- particularly those with sepsis.
Our hypothesis is that this requirement for a non-tourniquet blood draw is unnecessary.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Hypotensive, non pregnant by history, Emergency Medicine patients|
|Intervention ICMJE||Not Provided|
Hypotensive, non pregnant by history, non comfort care Emergency Department patients.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Suspended|
|Estimated Enrollment ICMJE||100|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00750516|
|Other Study ID Numbers ICMJE||5625|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|Plan to Share Data||Not Provided|
|IPD Description||Not Provided|
|Responsible Party||Mark Barasz MD, Emergency Medicine Department of Upstate Hospital|
|Study Sponsor ICMJE||State University of New York - Upstate Medical University|
|Collaborators ICMJE||Not Provided|
|Information Provided By||State University of New York - Upstate Medical University|
|Verification Date||June 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP