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

This study has suspended participant recruitment.
(Insufficient patient enrolled)
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00750516
First received: September 9, 2008
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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
Hypotension
Sepsis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2008
Groups/Cohorts
Lacid
Hypotensive, non pregnant by history, non comfort care Emergency Department patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hypotensive, non pregnant by history, Emergency Medicine patients

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant by history
  • Comfort care only
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750516

Locations
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
Investigators
Principal Investigator: Mark Barasz, MD Emergency Medicine Department ofUpstate Hospital
  More Information

No publications provided

Responsible Party: Mark Barasz MD, Emergency Medicine Department of Upstate Hospital
ClinicalTrials.gov Identifier: NCT00750516     History of Changes
Other Study ID Numbers: 5625
Study First Received: September 9, 2008
Last Updated: June 24, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypotension
Sepsis
Vascular Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014