Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of California, Los Angeles.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Olive View-UCLA Education & Research Institute
Information provided by (Responsible Party):
Richard Treger, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01624519
First received: June 18, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

The main objective of this study is to examine the agreement between arterial, central venous, and peripheral venous lactate values in a population of medical Intensive Care Unit (ICU) patients.


Condition Intervention
Blood Lactate Analysis
Procedure: Blood Lactate Analysis

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Agreement Between Arterial, Central Venous, and Peripheral Venous Lactate in the Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Agreement between peripheral venous, central venous, and arterial lactate values in a population of medical Intensive Care Unit (ICU) patients. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Procedure: Blood Lactate Analysis
When an arterial lactate is deemed to be necessary as part of ICU management, a central venous and peripheral venous sample will also obtained within 5 minutes. All of the samples will be analyzed using the same analyzer as quickly as possible.

Detailed Description:

This study is a single-center, prospective trial to assess the agreement between arterial, central venous, and peripheral venous lactate measurements. When an arterial lactate is deemed to be necessary as part of ICU management, a central venous and peripheral venous sample will also obtained within 5 minutes. All of the samples will be analyzed using the same analyzer as quickly as possible. A maximum of 10 paired arterial and venous lactate samples will be obtained per patient to prevent a single patient from dominating the data set. Additional data collected on a standardized data collection form will include primary diagnosis, intubation status, use of inotropic agents, hypotension (defined as a systolic blood pressure < 90 mm Hg), ICU length of stay and mortality. The Bland-Altman method will be used to assess agreement between arterial (A), central venous(CV), and peripheral venous (PV) lactate measurements. Approximately 50 patients will be enrolled in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients 18 years or older
  • Admitted to the Intensive Care Unit (ICU)
  • Determined by their treating clinicians to require both a central venous line and arterial line

Exclusion Criteria:

  • None
  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: NCT01624519

Contacts
Contact: Richard Treger, MD Rick.Treger@gmail.com

Sponsors and Collaborators
University of California, Los Angeles
Olive View-UCLA Education & Research Institute
Investigators
Principal Investigator: Rick Treger Olive View-UCLA
  More Information

Publications:

Responsible Party: Richard Treger, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01624519     History of Changes
Other Study ID Numbers: 10H-821002
Study First Received: June 18, 2012
Last Updated: June 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Arterial Lactate
Central Venous Lactate
Peripheral Venous Lactate

ClinicalTrials.gov processed this record on October 29, 2014