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

June 18, 2012 updated by: Richard Treger, University of California, Los Angeles
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Agreement between peripheral venous, central venous, and arterial lactate values in a population of medical Intensive Care Unit (ICU) patients.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

Olive View-UCLA Education & Research Institute

Investigators

  • Principal Investigator: Rick Treger, Olive View-UCLA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ANTICIPATED)

August 1, 2013

Study Completion (ANTICIPATED)

August 1, 2013

Study Registration Dates

First Submitted

June 18, 2012

First Submitted That Met QC Criteria

June 18, 2012

First Posted (ESTIMATE)

June 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 18, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10H-821002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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