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

This study is not yet open for participant recruitment.

Verified June 2012 by University of California, Los Angeles

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:

Drug Information available for: Lactic acid Ammonium lactate

U.S. FDA Resources

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

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:

BRODER G, WEIL MH. EXCESS LACTATE: AN INDEX OF REVERSIBILITY OF SHOCK IN HUMAN PATIENTS. Science. 1964 Mar 27;143(3613):1457-9.

Cowan BN, Burns HJ, Boyle P, Ledingham IM. The relative prognostic value of lactate and haemodynamic measurements in early shock. Anaesthesia. 1984 Aug;39(8):750-5.

Mizock BA. Controversies in lactic acidosis. Implications in critically ill patients. JAMA. 1987 Jul 24-31;258(4):497-501.

Domino EF, Bartolini A, Kawamura H. Effects of reticular stimulation, d-amphetamine and scopolamine on acetylcholine release from the hippocampus of brainstem transected cats. Arch Int Pharmacodyn Ther. 1977 Feb;225(2):294-302.

Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77.

Mortensen JD. Clinical sequelae from arterial needle puncture, cannulation, and incision. Circulation. 1967 Jun;35(6):1118-23. No abstract available.

Criscuolo C, Nepper G, Buchalter S. Reflex sympathetic dystrophy following arterial blood gas sampling in the intensive care setting. Chest. 1995 Aug;108(2):578-80. Review.

Weil MH, Michaels S, Rackow EC. Comparison of blood lactate concentrations in central venous, pulmonary artery, and arterial blood. Crit Care Med. 1987 May;15(5):489-90.

Murdoch IA, Turner C, Dalton RN. Arterial or mixed venous lactate measurement in critically ill children. Is there a difference? Acta Paediatr. 1994 Apr;83(4):412-3.

Middleton P, Kelly AM, Brown J, Robertson M. Agreement between arterial and central venous values for pH, bicarbonate, base excess, and lactate. Emerg Med J. 2006 Aug;23(8):622-4.

Gallagher EJ, Rodriguez K, Touger M. Agreement between peripheral venous and arterial lactate levels. Ann Emerg Med. 1997 Apr;29(4):479-83.

Younger JG, Falk JL, Rothrock SG. Relationship between arterial and peripheral venous lactate levels. Acad Emerg Med. 1996 Jul;3(7):730-4.

Adams J 2nd, Hazard P. Comparison of blood lactate concentrations in arterial and peripheral venous blood. Crit Care Med. 1988 Sep;16(9):913-4.

Klein WW, Brandt D, Kraft-Kinz J, Schreyer H. [Dynamics and metabolism in coronary heart disease before and after revascularization intervention]. Acta Med Austriaca. 1976;3(3):69-73. German.

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 June 17, 2013

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