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Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet

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ClinicalTrials.gov Identifier: NCT00750516
Recruitment Status : Suspended (Insufficient patient enrolled)
First Posted : September 10, 2008
Last Update Posted : June 25, 2009
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Study Description
Brief Summary:

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.

Condition or disease
Hypotension Sepsis

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Study Start Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Hypotensive, non pregnant by history, non comfort care Emergency Department patients.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hypotensive, non pregnant by history, Emergency Medicine patients

Inclusion Criteria:

  • Blood pressure systolic of 90 or less
  • Non pregnant by history

Exclusion Criteria:

  • Pregnant by history
  • Comfort care only
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750516

United States, New York
Upstate Hospital Emergency Department
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Principal Investigator: Mark Barasz, MD Emergency Medicine Department ofUpstate Hospital
More Information

Responsible Party: Mark Barasz MD, Emergency Medicine Department of Upstate Hospital
ClinicalTrials.gov Identifier: NCT00750516     History of Changes
Other Study ID Numbers: 5625
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Keywords provided by State University of New York - Upstate Medical University:
Lactic acid

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents