Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease (R34 pK/PD)

  • STATUS
    Recruiting
  • End date
    Jul 16, 2023
  • participants needed
    21
  • sponsor
    Emory University
Updated on 16 May 2022
opioid
arginine
thalassemia

Summary

The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.

Description

Arginine is a simple amino acid that is found in many foods and is part of the proteins in a human's body. Patients with sickle cell disease have low levels of the amino acid arginine and these low levels may be related to pain episodes. Increasing levels of arginine in the blood may lower pain and/or lower the amount of pain medication (like morphine) that is needed to treated them. It may also decrease the amount of time spent in the hospital.

Details
Condition Sickle Cell Disease
Treatment Arginine, Arginine (Loading), Arginine (Continuous)
Clinical Study IdentifierNCT02447874
SponsorEmory University
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia
-21 years of age
Weight >= 25kg (55lbs)
Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes

Exclusion Criteria

Decision to discharge home from acute care setting
Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)
Hemoglobin less than 5 gm/dL
Immediate Red cell transfusion anticipated
Hepatic dysfunction: serum glutamic pyruvic transaminase (SGPT) > 3X upper value
Renal dysfunction: Creatinine >1.0 or 2 x baseline
Mental status or neurological changes
Acute stroke or clinical concern for stroke
Pregnancy
Allergy to arginine
Previous hospitalization < 7 days
Previous randomization in this arginine pK study (patient consented and screened failed before receiving study drug or placebo remains eligible for future participation)
Use of inhaled nitric oxide, sildenafil or arginine within the last month
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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