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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01624519
Other study ID # 10H-821002
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 18, 2012
Last updated June 18, 2012
Start date August 2012
Est. completion date August 2013

Study information

Verified date June 2012
Source University of California, Los Angeles
Contact Richard Treger, MD
Email Rick.Treger@gmail.com
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles Olive View-UCLA Education & Research Institute

References & Publications (14)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

Mortensen JD. Clinical sequelae from arterial needle puncture, cannulation, and incision. Circulation. 1967 Jun;35(6):1118-23. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Agreement between peripheral venous, central venous, and arterial lactate values in a population of medical Intensive Care Unit (ICU) patients. 1 year No