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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00750516
Other study ID # 5625
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date September 2008
Est. completion date June 2009

Study information

Verified date April 2019
Source State University of New York - Upstate Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria:

- Blood pressure systolic of 90 or less

- Non pregnant by history

Exclusion Criteria:

- Pregnant by history

- Comfort care only

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Upstate Hospital Emergency Department Syracuse New York

Sponsors (1)

Lead Sponsor Collaborator
State University of New York - Upstate Medical University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in hypotensive patients between the use of a tourniquet and non tourniquet sampling for Lactic Acid level. At the initial evaluation of the patient
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