Boluses of Ringer's in Surgical Kids (BRiSK Study)

NCT05285371 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 21-019180
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Traditional protocols for intravenous fluid administration in children who have undergone a major abdominal or thoracic operation are based on a landmark paper published in 1957 by Holliday and Segar. The basic tenets include: (1) Continuous intravenous fluid administration; (2) Total fluid volume based on the "4:2:1" rule; (3) Use of hypotonic electrolyte solutions, most commonly 0.45% sodium chloride (NaCl) + 20 milliequivalents per liter (mEq/L) potassium chloride (KCl); and (4) Inclusion of 5% dextrose to increase the osmolarity of the infusate and to help prevent ketosis and acidemia.

Conditions

Dehydration in Children; Fluid Therapy

Keywords

Hydration; Fluids; Lactated Ringer's; Hyponatremia; Dehydration; Post Operative; Pediatrics; Children; Intravenous Fluid Therapy

Outcome Measures

Primary Outcomes (2)

• Fluid Adherence to Study Protocol

  Feasibility will be determined if 85% of enrolled study participants receive at least 75% of the expected study fluid in accordance to study protocol.

  4 Days

• Feasibility of Measuring and Collecting Urine Output

  Feasibility will be determined if at least 90% of enrolled study participants have accurate urine collection and urine measurements during the study treatment phase.

  4 Days

Secondary Outcomes (2)

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

  4 Days

• Feasibility of Randomization

  Baseline

Study Arms (2)

CONT Group

PLACEBO COMPARATOR

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

Diagnostic Test: Urinalysis (UA); Diagnostic Test: Complete Metabolic Panel (CMP); Diagnostic Test: Glucose Stick Test (d-Stick); Other: Medical Chart Review

BOL Group

EXPERIMENTAL

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

Diagnostic Test: Urinalysis (UA); Diagnostic Test: Complete Metabolic Panel (CMP); Diagnostic Test: Glucose Stick Test (d-Stick); Other: Medical Chart Review

Interventions

Urinalysis (UA) DIAGNOSTIC_TEST

Urinalysis will be performed twice daily starting on Postoperative Day 0.

BOL Group; CONT Group

Complete Metabolic Panel (CMP) DIAGNOSTIC_TEST

A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.

BOL Group; CONT Group

Glucose Stick Test (d-Stick) DIAGNOSTIC_TEST

A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.

BOL Group; CONT Group

Medical Chart Review OTHER

A medical chart review will be performed for all subjects enrolled.

BOL Group; CONT Group

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males or females age 12 months to 21 years.
• Weight \>= 8 kg.
• 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.
• Patients who will be inpatient for approximately 4-8 days postoperatively.
• Parental/guardian permission (informed consent).

You may not qualify if:

• Patients with a history of diabetes, seizures, hyperglycemia, and hypoglycemia.
• Patients prescribed insulin.
• Patients receiving parenteral nutrition.
• Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
• Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
• Patients with any form of hypersensitivity to the study fluids.
• Laboratory abnormalities that indicate clinically significant hematologic, hepatobiliary, or renal disease:
• Serum Sodium \<130 or \>145 mmol/L
• Serum Potassium \<3.0 or \>5.0 mEq/L
• Serum Chloride \<90 or \>110 mEq/L
• Serum Creatinine ≥ 1.6 mg/dL
• Serum Glucose \<60 or \>180 mg/dL
• Alanine Aminotransferase \>200 U/L
• Total Bilirubin \>12.0 mg/dL
• Pregnant or lactating females.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (20)

• McNab S. Intravenous maintenance fluid therapy in children. J Paediatr Child Health. 2016 Feb;52(2):137-40. doi: 10.1111/jpc.13076.

  PMID: 27062616 BACKGROUND

• Rooholamini SN, Clifton H, Haaland W, McGrath C, Vora SB, Crowell CS, Romero H, Foti J. Outcomes of a Clinical Pathway to Standardize Use of Maintenance Intravenous Fluids. Hosp Pediatr. 2017 Dec;7(12):703-709. doi: 10.1542/hpeds.2017-0099.

  PMID: 29162640 BACKGROUND

• Neville KA, Sandeman DJ, Rubinstein A, Henry GM, McGlynn M, Walker JL. Prevention of hyponatremia during maintenance intravenous fluid administration: a prospective randomized study of fluid type versus fluid rate. J Pediatr. 2010 Feb;156(2):313-9.e1-2. doi: 10.1016/j.jpeds.2009.07.059. Epub 2009 Oct 9.

  PMID: 19818450 BACKGROUND

• Bagri NK, Saurabh VK, Basu S, Kumar A. Isotonic versus Hypotonic Intravenous Maintenance Fluids in Children: A Randomized Controlled Trial. Indian J Pediatr. 2019 Nov;86(11):1011-1016. doi: 10.1007/s12098-019-03011-5. Epub 2019 Jul 6.

  PMID: 31280410 BACKGROUND

• Morgan JA. Question 2: Should 0.9% saline be used for maintenance fluids in hospitalised children? Arch Dis Child. 2015 Jul;100(7):715-7. doi: 10.1136/archdischild-2015-308821. Epub 2015 May 20. No abstract available.

  PMID: 25994003 BACKGROUND

• Moritz ML. Syndrome of Inappropriate Antidiuresis. Pediatr Clin North Am. 2019 Feb;66(1):209-226. doi: 10.1016/j.pcl.2018.09.005.

  PMID: 30454744 BACKGROUND

• Feld LG, Neuspiel DR, Foster BA, Leu MG, Garber MD, Austin K, Basu RK, Conway EE Jr, Fehr JJ, Hawkins C, Kaplan RL, Rowe EV, Waseem M, Moritz ML; SUBCOMMITTEE ON FLUID AND ELECTROLYTE THERAPY. Clinical Practice Guideline: Maintenance Intravenous Fluids in Children. Pediatrics. 2018 Dec;142(6):e20183083. doi: 10.1542/peds.2018-3083.

  PMID: 30478247 BACKGROUND

• Friedman JN, Beck CE, DeGroot J, Geary DF, Sklansky DJ, Freedman SB. Comparison of isotonic and hypotonic intravenous maintenance fluids: a randomized clinical trial. JAMA Pediatr. 2015 May;169(5):445-51. doi: 10.1001/jamapediatrics.2014.3809.

  PMID: 25751673 BACKGROUND

• Moritz ML, Ayus JC. Hospital-acquired hyponatremia--why are hypotonic parenteral fluids still being used? Nat Clin Pract Nephrol. 2007 Jul;3(7):374-82. doi: 10.1038/ncpneph0526.

  PMID: 17592470 BACKGROUND

• Oh GJ, Sutherland SM. Perioperative fluid management and postoperative hyponatremia in children. Pediatr Nephrol. 2016 Jan;31(1):53-60. doi: 10.1007/s00467-015-3081-y. Epub 2015 Mar 18.

  PMID: 25784018 BACKGROUND

• Abdessalam S. Hypotonic versus isotonic maintenance fluid administration in the pediatric surgical patient. Semin Pediatr Surg. 2019 Feb;28(1):43-46. doi: 10.1053/j.sempedsurg.2019.01.007. Epub 2019 Jan 23.

  PMID: 30824133 BACKGROUND

• McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A, Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. Cochrane Database Syst Rev. 2014 Dec 18;2014(12):CD009457. doi: 10.1002/14651858.CD009457.pub2.

  PMID: 25519949 BACKGROUND

• Easley D, Tillman E. Hospital-acquired hyponatremia in pediatric patients: a review of the literature. J Pediatr Pharmacol Ther. 2013 Apr;18(2):105-11. doi: 10.5863/1551-6776-18.2.105.

  PMID: 23798904 BACKGROUND

• Moritz ML, Ayus JC. Prevention of hospital-acquired hyponatremia: a case for using isotonic saline. Pediatrics. 2003 Feb;111(2):227-30. doi: 10.1542/peds.111.2.227.

  PMID: 12563043 BACKGROUND

• Malbrain MLNG, Langer T, Annane D, Gattinoni L, Elbers P, Hahn RG, De Laet I, Minini A, Wong A, Ince C, Muckart D, Mythen M, Caironi P, Van Regenmortel N. Intravenous fluid therapy in the perioperative and critical care setting: Executive summary of the International Fluid Academy (IFA). Ann Intensive Care. 2020 May 24;10(1):64. doi: 10.1186/s13613-020-00679-3.

  PMID: 32449147 BACKGROUND

• Bampoe S, Odor PM, Dushianthan A, Bennett-Guerrero E, Cro S, Gan TJ, Grocott MP, James MF, Mythen MG, O'Malley CM, Roche AM, Rowan K, Burdett E. Perioperative administration of buffered versus non-buffered crystalloid intravenous fluid to improve outcomes following adult surgical procedures. Cochrane Database Syst Rev. 2017 Sep 21;9(9):CD004089. doi: 10.1002/14651858.CD004089.pub3.

  PMID: 28933805 BACKGROUND

• Chin KJ, Macachor J, Ong KC, Ong BC. A comparison of 5% dextrose in 0.9% normal saline versus non-dextrose-containing crystalloids as the initial intravenous replacement fluid in elective surgery. Anaesth Intensive Care. 2006 Oct;34(5):613-7. doi: 10.1177/0310057X0603400511.

  PMID: 17061636 BACKGROUND

• Self WH, Semler MW, Wanderer JP, Wang L, Byrne DW, Collins SP, Slovis CM, Lindsell CJ, Ehrenfeld JM, Siew ED, Shaw AD, Bernard GR, Rice TW; SALT-ED Investigators. Balanced Crystalloids versus Saline in Noncritically Ill Adults. N Engl J Med. 2018 Mar 1;378(9):819-828. doi: 10.1056/NEJMoa1711586. Epub 2018 Feb 27.

  PMID: 29485926 BACKGROUND

• Maheshwari K, Turan A, Makarova N, Ma C, Esa WAS, Ruetzler K, Barsoum S, Kuhel AG, Ritchey MR, Higuera-Rueda C, Kopyeva T, Stocchi L, Essber H, Cohen B, Suleiman I, Bajracharya GR, Chelnick D, Mascha EJ, Kurz A, Sessler DI. Saline versus Lactated Ringer's Solution: The Saline or Lactated Ringer's (SOLAR) Trial. Anesthesiology. 2020 Apr;132(4):614-624. doi: 10.1097/ALN.0000000000003130.

  PMID: 31977517 BACKGROUND

• Farrell PR, Farrell LM, Hornung L, Abu-El-Haija M. Use of Lactated Ringers Solution Compared With Normal Saline Is Associated With Shorter Length of Stay in Pediatric Acute Pancreatitis. Pancreas. 2020 Mar;49(3):375-380. doi: 10.1097/MPA.0000000000001498.

  PMID: 32132512 BACKGROUND

MeSH Terms

Conditions

Hyponatremia; Dehydration

Interventions

Urinalysis

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Investigative Techniques

Study Officials

• Peter Mattei, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will be randomized into one of two groups - Continuous (CONT) or Bolus (BOL). CONT group will receive traditional continuous D50.45% NaCl + 20 mEq/L KCl solution at 2/3 maintenance rate. BOL group will receive intravenous boluses of Lactated Ringer\&#39;s at 2/3-maintenance rate.

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: February 22, 2022
• Primary Completion: April 19, 2023
• Study Completion: August 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)