Arginine Treatment for Pain Crises in Children With Sickle Cell Disease

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young people with severe sickle cell disease who have a painful event and need strong pain medicine given by injection or drip in an acute care setting.

Age

7 to 21 years

Sex

All sexes can join.

Disease stage

Sickle cell disease of type Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia, with pain needing medical care in an acute care setting and parenteral opioids, not caused by something other than sickle cell disease.

Earlier treatment

Cannot have used inhaled nitric oxide, sildenafil or arginine in the last 14 days. Cannot have been in hospital in the last 7 days.

Biomarker or test result

Weight of 25kg (55 lb (25 kg)) (55lbs (25 kg)) or more. Hemoglobin of 5 gm/dL or more.

Main reasons for not taking part

• Decision to send the person home from acute care
• Other types of sickle cell disease, such as HbSC, HbSD, HbSE, HbSO or Hb AS carrier
• Kidney problems (creatinine >1.0 or 2 x baseline)
• Stroke, concern for stroke, or changes in mental status or nervous system
• Pregnancy or allergy to arginine

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 7 and 21 years old?YesNo

What the trial wants to find out

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.

The 6 groups in the trial

• Standard doseTreatment being tested

  Subjects with sickle cell disease (SCD) and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of a standard dose of arginine (100 mg/kg) three times a day for seven days or until discharged from the hospital, whichever occurs first

  Treatment: Arginine

• Loading dose + standard doseTreatment being tested

  Subjects with sickle cell disease and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of an initial loading dose of arginine (200 mg/kg) given over 30 minutes and then receive an intravenous (IV) infusion of a standard dose of arginine (100 mg/kg) three times a day for seven days or until discharged from the hospital, whichever occurs first

  Treatment: Arginine and Arginine (Loading)

• Loading dose + continuous infusionTreatment being tested

  Subjects with sickle cell disease and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of an initial loading dose of arginine (200 mg/kg) given over 30 minutes and then receive a continuous intravenous (IV) infusion of 300 mg/kg/24hr for 7 days or until discharged from the hospital, whichever occurs first

  Treatment: Arginine (Loading) and Arginine (Continuous)

• Non-Randomized Loading dose 500 mg/kg + standard doseTreatment being tested

  Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 500 mg/kg once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

  Treatment: Arginine (Loading)

• Non-Randomized Loading dose 300 mg/kg + standard doseTreatment being tested

  Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 300 mg/kg once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

  Treatment: Arginine (Loading)

• Non-Randomized Loading dose 400mg/kg + standard doseTreatment being tested

  Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 400 mg/kg once, followed by a standard dose of 100mg/kg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.

  Treatment: Arginine (Loading)