What side effects are associated with this type of intervention?

Common treatments for Acute Kidney Injury (AKI) include supportive care such as fluid management, electrolyte correction, and renal replacement therapy (dialysis). Potential side effects of these treatments can include fluid overload, electrolyte imbalances (such as hyperkalemia or hypocalcemia), and complications related to dialysis such as infection, hypotension, and vascular access issues. Pharmacologic interventions, though less common, may include diuretics and vasopressors, which can cause side effects like dehydration, electrolyte disturbances, and increased blood pressure.

What prior FDA approvals exist?

As of now, there are no FDA-approved pharmacological treatments specifically for Acute Kidney Injury (AKI). Management of AKI primarily involves supportive care, such as optimizing fluid balance, avoiding nephrotoxic agents, and treating the underlying cause. While caffeine citrate is being investigated for kidney protection in neonates with hypoxic ischemic encephalopathy, it is not yet approved for AKI treatment. Other investigational therapies, such as various antioxidants and anti-inflammatory agents, have not demonstrated consistent benefits in clinical trials.

What other types of research exist?

Promising, novel alternatives to caffeine citrate for kidney protection in acute kidney injury patients include sodium bicarbonate, theophylline, and antioxidants like N-acetylcysteine. These agents have shown potential in preventing renal damage in various contexts and may offer nephroprotective benefits.

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Methylxanthine

Caffeine Citrate for Newborn Brain Injury

Phase 1

Waitlist Available

Led By Jennifer Rumpel, MD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newborns ≥ 35 weeks GA admitted to the ACH NICU less than 24 hours of life

Be younger than 18 years old

Must not have

Genetic or congenital condition that affects renal function (e.g., congenital anomalies of the kidney and urinary tract (CAKUT), complex congenital heart disease)

Theophylline, aminophylline, or caffeine exposure prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if caffeine can protect the kidneys of newborns with brain injury due to lack of oxygen at birth. These babies are at high risk for kidney problems, and current treatments are limited. Caffeine might help by improving urine output and reducing kidney damage.

Who is the study for?

This trial is for newborns at least 35 weeks old with hypoxic ischemic encephalopathy, undergoing cooling therapy to treat brain injury caused by oxygen deprivation. Babies can't join if they have genetic conditions affecting the kidneys, severe ongoing seizures, or prior exposure to similar drugs like theophylline.

What is being tested?

The study tests how safe caffeine citrate is for these babies and how their bodies handle the drug. It's a first step in exploring whether caffeine can protect their kidneys during this critical time.

What are the potential side effects?

As it's an early-phase trial focusing on safety and dosage levels, specific side effects are being determined; however, typical caffeine-related side effects may include jitteriness, increased heart rate, and digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My newborn was admitted to the NICU within 24 hours of birth and was at least 35 weeks gestational age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a genetic condition that affects my kidney function.

Select...

I have not taken theophylline, aminophylline, or caffeine before joining.

Select...

I have had a very long seizure or needed many medicines to control my seizures.

Select...

My baby's parents are unable to give informed consent due to diminished capacity or autonomy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the plasma concentration-time curve of caffeine

Clearance of caffeine

Peak plasma concentration (Cmax) of caffeine

+3 more

Secondary study objectives

Acute kidney injury

Renal near infrared spectroscopy (NIRS)

Urine interleukin-18 (IL-18) (pg/mL)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Arm 2: Medium dose caffeineActive Control1 Intervention

Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 2 neonates will receive medium dose intravenous caffeine citrate (15 mg/kg).

Group II: Arm 3: High dose caffeineActive Control1 Intervention

Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 3 neonates will receive high dose intravenous caffeine citrate (25 mg/kg).

Group III: Arm 1: Low dose caffeineActive Control1 Intervention

Each neonate will receive a single dose of caffeine citrate in the first 24 hours of life. Arm 1 neonates will receive low dose intravenous caffeine citrate (5 mg/kg).

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Kidney Injury (AKI) include fluid resuscitation, diuretics, and renal replacement therapy. Fluid resuscitation aims to restore blood flow to the kidneys, improving perfusion and oxygen delivery. Diuretics help to manage fluid overload and reduce kidney swelling. Renal replacement therapy, such as dialysis, removes waste products and excess fluids when the kidneys are not functioning adequately. These treatments are crucial for stabilizing kidney function and preventing further damage. Caffeine citrate, being studied for its kidney protective properties, may work by enhancing renal blood flow and reducing inflammation, potentially offering a novel approach to support kidney function in AKI patients.