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...
Date First Received: September 9, 2008
Last Updated: June 24, 2009
Verified by: State University of New York - Upstate Medical University, June 2009
Clinical Trial Phase: N/A | Start Date: September 2008
Overall Status: Suspended
Estimated Enrollment: 100
Brief Summary
Official Title: “Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet”
Condition Keyword(s):
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.
Study Type: Observational
Study Design: Case Control, Prospective
Arms, Groups and Cohorts in this Clinical Trial
- : Lacid
- Hypotensive, non pregnant by history, non comfort care Emergency Department patients.
Outcome Measures for this Clinical Trial
Primary Measures
- 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
Safety Issue?: No
- Time Frame: At the initial evaluation of the patient
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Blood pressure systolic of 90 or less
- Non pregnant by history
Exclusion Criteria:
- Pregnant by history
- Comfort care only
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: State University of New York - Upstate Medical University
Overall Clinical Trial Officials and Contacts
Mark Barasz, MD Principal Investigator Emergency Medicine Department ofUpstate Hospital
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00750516
Study ID Number: 5625
ClinicalTrials.gov Identifier: NCT00750516
Health Authority: United States: Institutional Review Board
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