Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
70 participants
INTERVENTIONAL
2022-02-22
2024-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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\'s at 2/3-maintenance rate.
TREATMENT
NONE
Study Groups
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CONT Group
CONT group will receive standard traditional intravenous fluid of D50.45% NaCl + 20 mEq/L KCl at 2/3 maintenance rate.
Urinalysis (UA)
Urinalysis will be performed twice daily starting on Postoperative Day 0.
Complete Metabolic Panel (CMP)
A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.
Glucose Stick Test (d-Stick)
A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.
Medical Chart Review
A medical chart review will be performed for all subjects enrolled.
BOL Group
BOL group will receive intravenous boluses of Lactated Ringer's three times daily at 2/3 maintenance rate.
Urinalysis (UA)
Urinalysis will be performed twice daily starting on Postoperative Day 0.
Complete Metabolic Panel (CMP)
A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.
Glucose Stick Test (d-Stick)
A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.
Medical Chart Review
A medical chart review will be performed for all subjects enrolled.
Interventions
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Urinalysis (UA)
Urinalysis will be performed twice daily starting on Postoperative Day 0.
Complete Metabolic Panel (CMP)
A CMP will be performed on Postoperative Day 2 and Postoperative Day 4.
Glucose Stick Test (d-Stick)
A d-Stick will be performed twice daily except on Postoperative Day 2 and Postoperative Day 4 as the CMP includes serum glucose levels.
Medical Chart Review
A medical chart review will be performed for all subjects enrolled.
Eligibility Criteria
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Inclusion Criteria
2. Weight \>= 8 kg.
3. 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.
4. Patients admitted to a regular bed following surgery.
5. Patients who will be inpatient for approximately 4-8 days postoperatively.
6. Parental/guardian permission (informed consent).
Exclusion Criteria
2. Patients prescribed insulin.
3. Patients receiving parenteral nutrition.
4. Patients with excessive GI losses (small bowel obstruction, severe diarrhea, large-volume ascites or drainage).
5. Complicated surgery that requires an ICU or ICU transfer immediately after surgery.
6. Patients with any form of hypersensitivity to the study fluids.
7. 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
8. Pregnant or lactating females.
9. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
1 Year
21 Years
ALL
Yes
Sponsors
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Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Peter Mattei, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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McNab S. Intravenous maintenance fluid therapy in children. J Paediatr Child Health. 2016 Feb;52(2):137-40. doi: 10.1111/jpc.13076.
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.
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.
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.
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.
Moritz ML. Syndrome of Inappropriate Antidiuresis. Pediatr Clin North Am. 2019 Feb;66(1):209-226. doi: 10.1016/j.pcl.2018.09.005.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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21-019180
Identifier Type: -
Identifier Source: org_study_id
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