Viewing Study NCT00750516


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Study NCT ID: NCT00750516
Status: None
Last Update Posted: 2019-04-04 00:00:00
First Post: 2008-09-09 00:00:00
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Sponsor: None
Organization:

Study Overview

Official Title: Lactic Acid Levels In Hypotensive Patients Without(Standard) and With Tourniquet
Status: None
Status Verified Date: 2019-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Insufficient patient enrolled
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: