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Protocol - Lactate Dehydrogenase Level

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Protocol Name from Source:

This section will be completed when reviewed by an Expert Review Panel.

Availability:

Publicly available

Description:

This protocol provides instructions for drawing, processing, and storing blood according to the National Health and Nutrition Examination Survey (NHANES) methods. Because there are many comparable assays for measuring lactate dehydrogenase, the protocol also provides basic guidelines to aid comparability among different studies.

Protocol:

The following is a summary version of the full National Health and Nutrition Examination Survey 2011-2012 protocol.

Exclusion Criteria

Persons will be excluded from this component if they:

  • Report that they have hemophilia; or
  • Report that they have received cancer chemotherapy in the last 4 weeks

SP = Sample Person.

1. Do you have hemophilia?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If SP answers "No" or "Don’t Know," blood is drawn from the SP.

2. Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks?

1 [ ] Yes

2 [ ] No

7 [ ] Refused

9 [ ] Don’t Know

If the SP answers "Yes," the SP is excluded from the blood draw.

If SP answers "No" or "Don’t Know," blood is drawn from the SP.

Venipuncture Procedures

Editor’s Note: Please review chapter 4 of the Laboratory Procedures Manual from the 2011-2012 National Health and Nutrition Examination Survey (NHANES) for a full description of phlebotomy procedures. This manual is posted [link[www.phenx.org/Portals/0/phenx-content/Supplements/SickleCell/WG1/DocumentsForReview/Documents_for_Additional_Information/2011-12_Laboratory_Procedures_Manual.pdf|here]], and is also available at the NHANES website: [link[www.cdc.gov/nchs/data/nhanes/nhanes_11_12/2011-12_Laboratory_Procedures_Manual.pdf|2011-2012 NHANES Laboratory Procedures Manual]]

Venipuncture should generally be performed using the median cubital, cephalic, or basilic veins in the left arm unless this arm is unsuitable. If the veins in the left arm are unsuitable, look for suitable veins on the right arm. If the veins in the antecubital space on both arms are not suitable, then look for veins in the forearm or dorsal side of the hand on the left arm/hand and then the right arm/hand.

Recording the Results of the Venipuncture Procedure

Immediately after completing the venipuncture, record the results of the blood draw, the reasons for a tube not being drawn according to the protocol, and any comments about the venipuncture.

Blood Processing

Please review chapter 8 of the Laboratory Procedures Manual from the National Health and Nutrition Examination Survey 2011-2012 for a full description of blood processing procedures: [link[www.cdc.gov/nchs/data/nhanes/nhanes_11_12/2011-12_Laboratory_Procedures_Manual.pdf|2011-2012 NHANES Laboratory Procedures Manual]]

  • Allow the blood to clot by setting aside for 30 to 45 minutes at room temperature. Do not clot for more than an hour.
  • Centrifuge the tube at room temperature to separate the serum and aliquot into an appropriate storage tube.
  • Determine if the serum is hemolyzed, turbid, lipemic, or icteric. If so, enter a comment to describe the serum.

Pediatric blood collection - volumes may change depending on the laboratory but volumes as low as 0.5mL in a red top, green top or no additive tube/Microtainer™ have been used.

Laboratory Assay for Lactate Dehydrogenase

The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that there are a number of different assays and instruments that are appropriate to measure the concentration of lactate dehydrogenase. Once an assay is chosen for a particular study, the Working Group recommends that no changes in the protocol be made over the course of the study. To aid comparability, the Working Group recommends that the investigator record the make and manufacturer of equipment used and the repeatability and coefficients of variation for the assay.

Reference Ranges for Lactate Dehydrogenase:

Age (years)

IU/L

0-5

140-304

5-10

142-290

10-15

115-257

>15

93-198

Personnel and Training Required

Phlebotomist

Equipment Needs

Laboratory with the ability to perform the lactate dehydrogenase assay.

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Toddler, Child, Adolescent, Adult, Senior, Pregnancy

Specific Instructions:

The National Health and Nutrition Examination Survey (NHANES) instructions for drawing, processing, and storing blood provide a standard methodology used successfully for many years to ensure comparable results across study sites. However, the Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group notes that certain aspects (e.g., exclusion criteria) of the NHANES protocol are study specific and might not be applicable to all types of studies (e.g., sickle cell disease). Investigators who want to include participants that have hemophilia or have received cancer chemotherapy in the last 4 weeks will need to implement special venipuncture procedures.

Lactate dehydrogenase (LDH) levels can be combined with other indirect markers of hemolysis ([mlink[811200|Aspartate Aminotransferase Level]], [mlink[810800|Haptoglobin Level]], [mlink[810600|Reticulocyte]], and [mlink[810900|Bilirubin Level]]) to derive a hemolytic component for sickle cell disease patients.

LDH levels are increased with ineffective erythropoiesis and damage to liver, muscles, brain, heart, lungs, and other organs which are impacted by sickle cell disease.

LDH analysis is typically preformed via a serum assay using a serum gel separator collection tube.

Research Domain Information

Release Date:

July 30, 2015

Definition

A bioassay to measure levels of lactate dehydrogenase, an enzyme released during tissue damage and injury.

Purpose

Elevated lactate dehydrogenase (LDH) levels are reflective of increased hemolysis in sickle cell disease. Additionally, elevated LDH levels are associated with cancer, tissue damage, hemolysis and anemia, and infectious diseases such as HIV and bacterial meningitis.

Selection Rationale

The Sickle Cell Disease Cardiovascular, Pulmonary, and Renal Working Group selected the National Health and Nutrition Examination Survey 2011-2012 protocol as the best standardized methodology for blood collection, processing and storage.

Language

English

Standards

StandardNameIDSource
Common Data Elements (CDE)Laboratory Procedure Lactate Dehydrogenase Result Unspecified Value2597018CDE Browser

Process and Review

This section will be completed when reviewed by an Expert Review Panel.

Source

Centers for Disease Control and Prevention (CDC). (2011). National Health and Nutrition Examination Survey Questionnaire, Laboratory Procedures Manual. Hyattsville, MD: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention.

Burtis, C. A., Ashwood, E. R., & Bruns, D.E. (2006). Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th ed. St. Louis, MO: Elsevier Saunders.

General References

Potoka, K. P. & Gladwin, M. T. (2015). Vasculopathy and pulmonary hypertension in sickle cell disease. American Journal of Physiology - Lung Cellular and Molecular Physiology, 308: L314-L324

Nouraie, M., Lee, J. S., Zhang, Y., Kanias, T., Zhao, X., Xiong, Z., Oriss, T. B., Zeng, Q., Kato, G. J., Gibbs, J. S., Hildesheim, M. E., Sachdev, V., Barst, R. J., Machado, R. F., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E., Girgis, R. E., Morris, C.R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Goldsmith, J. C., Gordeuk, V. R., Galdwin, M. T., & Walk-PHASST Investigators and Patients. (2013). The relationship between the severity of hemolysis, clinical manifestations and risk of death in 415 patients with sickle cell anemia in the US and Europe. Haematologica, 98(3), 464-472.

Sachdev, V., Kato, G. J., Gibbs, J. S., Barst, R. J., Machado, R. F., Nouraie, M., Hassell, K. L., Little, J. A., Schraufnagel, D. E., Krishnamurti, L., Novelli, E. M., Girgis, R. E., Morris, C. R., Rosenzweig, E. B., Badesch, D. B., Lanzkron, S., Castro, O. L., Taylor, J. G. 6th, Hannoush, H., Goldsmith, J. C., Gladwin, M. T., Gordeuk, V. R., & Walk-PHASST Investigators. (2011). Echocardiographic markers of elevated pulmonary pressure and left ventricular diastolic dysfunction are associated with exercise intolerance in adults and adolescents with homozygous sickle cell anemia in the United States and United Kingdom. Circulation, 124(13), 1452-1460.

Protocol ID:

811001

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX811001_Lactate_Dehydrogenase_HemophiliaPX811001010000Do you have hemophilia?4N/A
PX811001_Lactate_Dehydrogenase_Chemotheraphy_4weeksPX811001020000Have you received cancer chemotherapy in the past four weeks or do you anticipate such therapy in the next four weeks?4N/A
PX811001_Lactate_Dehydrogenase_AgePX811001030000Age4N/A
PX811001_Lactate_Dehydrogenase_Blood_Draw_ResultsPX811001040000Record the results of the blood draw.4N/A
PX811001_Lactate_Dehydrogenase_Blood_DrawTube_DeviationPX811001050000Record reasons for a tube not being drawn according to the protocol.4N/A
PX811001_Lactate_Dehydrogenase_Venipuncture_CommentsPX811001060000Record any comments about the venipuncture.4N/A
PX811001_Lactate_Dehydrogenase_Serum_DeterminationPX811001070100Determine if the serum is hemolyzed, turbid, lipemic, or icteric.4N/A
PX811001_Lactate_Dehydrogenase_Serum_DescriptionPX811001070200If serum is hemolyzed, turbid, lipemic, or iteric, then describe.4N/A
PX811001_Lactate_Dehydrogenase_ConcentrationPX811001080000Lactate dehydrogenase level4N/A
PX811001_Lactate_Dehydrogenase_Equipment_MakePX811001090000Make of the equipment used to perform the lactate dehydrogenase assay.4N/A
PX811001_Lactate_Dehydrogenase_Equipment_ManufacturerPX811001100000Manufacturer of the equipment used to perform the lactate dehydrogenase assay.4N/A
PX811001_Lactate_Dehydrogenase_Assay_RepeatabilityPX811001110000Repeatability of the lactate dehydrogenase assay.4N/A
PX811001_Lactate_Dehydrogenase_Coefficients_Variation_AssayPX811001120000Coefficients of variation of the lactate dehydrogenase assay.4N/A