Near Infrared Spectroscopy in Sickle Cell Pediatric Patients

NCT ID: NCT04031521

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2023-09-03

Brief Summary

Endothelial dysfunction contributes to vaso-occlusion and acute pain in sickle cell disease. Near infrared spectroscopy (NIRS) technology can measure tissue oxygenation and endothelial function. The main objective of this study is to study the natural history of tissue muscle oxygenation using NIRS in pediatric sickle cell subjects experiencing acute pain and pediatric sickle cell patients in steady-state.

Conditions

Sickle Cell Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Sickle cell pain crisis

Near infrared spectroscopy

Intervention Type: DIAGNOSTIC_TEST

NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.

Sickle cell steady-state

Near infrared spectroscopy

Intervention Type: DIAGNOSTIC_TEST

NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.

Interventions

Near infrared spectroscopy

NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age 6 to 21 years old.

2. Diagnosis of sickle cell anemia: a. Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required).

3. Acute onset pain crisis in a distribution typical for that subject, onset within the last 7 days and for which hospitalization and parenteral narcotic pain treatment are required.

4. Ability to provide informed written consent.

1. Age 6-21 years

2. Diagnosis of sickle cell disease (electrophoresis or HPLC documentation of hemoglobin SS, SC, S-beta-thalassemia or other hemoglobinopathies causing sickle cell disease is required).

3. Ability to provide informed written consent.

Exclusion Criteria

1. Pregnancy.

2. History of non-trivial injury, burns, surgery or skin ulcers on the arms.

3. Fever or suspected sepsis at time of pain crisis

4. Administration of any of the following drugs within the last 14 days:

• Phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil)
• Endothelin-1 receptor blockers (bosentan, sitaxentan, ambrisentan, tezosentan)
• Nitric oxide donors (nitroglycerin, nitroprusside, nitrates)

5. Ingestion of caffeine within the 12 hours before the start of the study appointment, or tobacco use within the 30 days before the study appointment.

6. Diagnosis with any of the following chronic diseases or conditions:

• History of high blood pressure
• History of high cholesterol
• History of diabetes
• History of chronic kidney disease (serum creatinine must not be greater than 2 mg/dL)
• History of coronary artery disease or peripheral vascular disease

7. Received a blood transfusion within 7 days of the study procedure.

1. Pregnancy.

2. History of non-trivial trauma, burns, surgery or skin ulcers on the arms.

3. Fever or suspected sepsis at time of pain crisis

4. Experience of an acute pain crisis requiring intravenous (IV) narcotics and hospital admission within the last 14 days.

5. Ingestion of caffeine within the 12 hours before the start of the study appointment, or tobacco use within the 30 days before the study appointment.

6. Administration of any of the following drugs within the last 14 days:

• Phosphodiesterase-5 inhibitors (sildenafil, vardenafil, tadalafil)
• Endothelin-1 receptor blockers (bosentan, sitaxentan, ambrisentan, tezosentan)
• Nitric oxide donors (nitroglycerin, nitroprusside, nitrates)

7. Diagnosis of any of the following chronic diseases or conditions:

• History of high blood pressure
• History of high cholesterol
• History of diabetes
• History of chronic kidney disease (serum creatinine must not be greater than 2 mg/dL)
• History of coronary artery disease or peripheral vascular disease

8. Received a blood transfusion within 7 days of the study procedure.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Children's National Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Suvankar Majumdar

Chief of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's National Medical Center

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

Pro00012424

Identifier Type: -

Identifier Source: org_study_id