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Liberal Fluid Protocol for Post-Surgical Fluid Management in Children (BRiSK Trial)

Q: What is the enrolment capacity for this clinical exploration?

Affirmative. According to the details found on clinicaltrials.gov, this medical investigation is actively enrolling patients at present. The trial was first posted in February 22nd 2022 and has been updated as recently as September 22nd 2022, with 70 participants sought from a single location.

Q: Is this clinical trial open to seniors aged sixty and older?

This research initiative is looking for participants between the ages of 1 and 21.

Q: Am I eligible to volunteer for this trial?

This clinical trial is recruiting 70 individuals aged between 1 Year and 21 who require fluid therapy. Additionally, participants must register a weight of 8 kg or more, have experienced an uncomplicated abdominal/thoracic surgery with a minimum 2-5 day postoperative period, be admitted to a regular bed after the procedure, plan on staying inpatient for 4-8 days afterwards, receive parental/guardian consent (informed permission) and identify as male or female age 12 months to 21 years.

Q: Is recruitment still open for this research trial?

Affirmative. The clinicaltrials.gov website states that this medical research is actively looking for volunteers, with the trial having been initially posted on February 22nd 2022 and recently updated on September 22nd 2022. 70 persons are being sought to participate at one particular site.

Phase < 1

Waitlist Available

Led By Peter Mattei, MD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Patients with an uncomplicated abdominal or thoracic surgical procedure in which the expected postoperative length of stay is anticipated to be at least 2-5 days

Patients admitted to a regular bed following surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 days

Awards & highlights

BRiSK Trial Summary

This trial found that using a more liberal fluid protocol, which included higher rates of infusion and larger volumes of fluid, was associated with improved outcomes in children who had undergone major abdominal surgery.

Who is the study for?

The BRiSK Study is for kids aged 12 months to 21 years who've had uncomplicated abdominal or thoracic surgery and weigh at least 8 kg. They should be staying in the hospital for about 2-5 days post-surgery. Kids with diabetes, seizures, certain blood sugar issues, or those on parenteral nutrition can't join.Check my eligibility

What is being tested?

This study reviews medical charts and performs tests like urinalysis and blood panels to evaluate traditional IV fluid protocols in children after major surgeries. It questions the continuous use of a specific fluid mix based on guidelines from over six decades ago.See study design

What are the potential side effects?

Since this trial involves standard postoperative care procedures rather than new medications, side effects are not a primary concern as they would be with drug trials. However, risks may include typical complications related to IV fluid therapy.

BRiSK Trial Eligibility Criteria

Inclusion Criteria

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

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I had a surgery in my chest or belly area and stayed in the hospital for 2-5 days.

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I was admitted to a regular hospital bed after my surgery.

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I weigh at least 8 kilograms.

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I am between 12 months and 21 years old.

BRiSK Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility of Measuring and Collecting Urine Output

Fluid Adherence to Study Protocol

Secondary outcome measures

Feasibility of Randomization

Feasibility of Study Laboratory Tests - CMP, d-Stick, Urinalysis

BRiSK Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BOL GroupExperimental Treatment4 Interventions

BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.

Group II: CONT GroupPlacebo Group4 Interventions

CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital of PhiladelphiaLead Sponsor

708 Previous Clinical Trials

8,581,205 Total Patients Enrolled

Peter Mattei, MDPrincipal InvestigatorChildren's Hospital of Philadelphia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrolment capacity for this clinical exploration?

"Affirmative. According to the details found on clinicaltrials.gov, this medical investigation is actively enrolling patients at present. The trial was first posted in February 22nd 2022 and has been updated as recently as September 22nd 2022, with 70 participants sought from a single location."

Answered by AI

Is this clinical trial open to seniors aged sixty and older?

"This research initiative is looking for participants between the ages of 1 and 21."

Answered by AI

Am I eligible to volunteer for this trial?

"This clinical trial is recruiting 70 individuals aged between 1 Year and 21 who require fluid therapy. Additionally, participants must register a weight of 8 kg or more, have experienced an uncomplicated abdominal/thoracic surgery with a minimum 2-5 day postoperative period, be admitted to a regular bed after the procedure, plan on staying inpatient for 4-8 days afterwards, receive parental/guardian consent (informed permission) and identify as male or female age 12 months to 21 years."

Answered by AI

Is recruitment still open for this research trial?

"Affirmative. The clinicaltrials.gov website states that this medical research is actively looking for volunteers, with the trial having been initially posted on February 22nd 2022 and recently updated on September 22nd 2022. 70 persons are being sought to participate at one particular site."

Answered by AI

Recent research and studies

PancreasJournal

Use of Lactated Ringers Solution Compared with Normal Saline Is Associated with Shorter Length of Stay in Pediatric Acute Pancreatitis

Farrell, Peter R., Leslie M. Farrell, Lindsey Hornung, and Maisam Abu-El-Haija. 2020. “Use of Lactated Ringers Solution Compared with Normal Saline Is Associated with Shorter Length of Stay in Pediatric Acute Pancreatitis”. Pancreas. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/mpa.0000000000001498.

versusJournal

Saline versus Lactated Ringer’s Solution

Maheshwari, Kamal, Alparslan Turan, Natalya Makarova, Chao Ma, Wael Ali Sakr Esa, Kurt Ruetzler, Sabri Barsoum, et al.. 2020. “Saline versus Lactated Ringer’s Solution”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000003130.

Journal of Paediatrics and Child HealthJournal

Intravenous Maintenance Fluid Therapy in Children

McNab, Sarah. 2016. “Intravenous Maintenance Fluid Therapy in Children”. Journal of Paediatrics and Child Health. Wiley. doi:10.1111/jpc.13076.

Pediatric NephrologyJournal