drugset / Trial / NCT04102371
Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis
Phase 3
Completed
9041 enrolled
Children's Hospital of Philadelphia
Alberta Children's Hospital · collabAnn & Robert H Lurie Children's Hospital of Chicago · collabBaylor College of Medicine · collabBoston Children's Hospital · collabBritish Columbia Children's Hospital · collabCentre Hospitalier Univeritaire Sainte Justine · collabCentre Hospitalier Universitaire de Quebec · collabChildren's Healthcare of Atlanta · collabChildren's Hospital Colorado · collabChildren's Hospital Los Angeles · collabChildren's Hospital Medical Center, Cincinnati · collabChildren's Hospital and Health System Foundation, Wisconsin · collabChildren's Hospital of Eastern Ontario · collabChildren's Medical Center Dallas · collabChildren's National Research Institute · collabEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collabGold Coast Hospital and Health Service · collabHasbro Children's Hospital · collabHospital nacional de niños Costa Rica · collabIWK Health Centre · collabJim Pattison Children's Hospital · collabKidz First Hospital Middlemore · collabKingston Health Sciences Centre · collabLondon Health Sciences Centre · collabMcMaster Children's Hospital · collabMonash Children's Hospital · collabMorgan Stanley Children's Hospital · collabNationwide Children's Hospital · collabPennsylvania Department of Health · collabPerth Children's Hospital · collabPrimary Children's Hospital · collabQueensland Children's Hospital · collabRoyal Children's Hospital · collabRoyal Darwin Hospital · collabSeattle Children's Hospital · collabSt. Louis Children's Hospital · collabStarship Children's Hospital · collabStollery Children's Hospital · collabSydney Children's Hospitals Network · collabThe Children's Hospital of Winnipeg · collabThe Hospital for Sick Children · collabTownsville University Hospital · collabUniversity of California, Davis · collabUniversity of California, San Francisco · collabUniversity of Michigan · collabUniversity of Pittsburgh · collabVirginia Commonwealth University · collabWestmead Children's Hospital · collabWomen's and Children's Hospital, Australia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The objectives of this multicenter pragmatic clinical trial are to compare the effectiveness and relative safety of balanced fluid resuscitation versus 0.9% "normal" saline in children with septic shock, including whether balanced fluid resuscitation can reduce progression of kidney injury.
Timeline
- Start
- 2020-08-25
- Primary completion
- 2025-12-01
- Completion
- 2026-01-31
Publications
- Background Balamuth F, Kittick M, McBride P, Woodford AL, Vestal N, Casper TC, Metheney M, Smith K, Atkin NJ, Baren JM, Dean JM, Kuppermann N, Weiss SL. Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study. Acad Emerg Med. 2019 Dec;26(12):1346-1356. doi: 10.1111/acem.13815. Epub 2019 Jul 18.
- Balamuth F, Weiss SL, Long E, Thompson GC, Artis AS, Campos AB, Borland ML, Dalziel SR, Yock-Corrales A, Singh R, Williams A, Mickiewicz B, Hickey CP, Fitzgerald JC, Laskin BL, Hickey RW, Eckerle M, Alqurashi W, Alpern E, Ambroggio L, Badawy M, Baumer-Mouradian S, Berthelot S, Clukies LD, Craig S, Curtis SJ, Davis AL, Duffy S, Eisenberg MA, Emsley JG, Festekjian A, George S, Green R, Gripp KE, Jain PG, Jani S, Joubert GI, Judge P, Kam A, Kochar A, Koutroulis I, Kwok MY, Lane RD, Lithgow A, Lloyd J, Mansour K, McManemy JK, Morris C, Phillips N, Rao A, Rogers A, Sehgal A, Shayan Y, Silverman J, Tan E, Uspal NG, Vance C, Whyte E, Huang J, Freedman SB, Babl FE, Kuppermann N; PRoMPT BOLUS Investigators of the PECARN, PERC, and PREDICT Networks. Balanced Fluid or 0.9% Saline in Children Treated for Septic Shock. N Engl J Med. 2026 Apr 24:10.1056/NEJMoa2601969. doi: 10.1056/NEJMoa2601969. Online ahead of print.
- Weiss SL, Balamuth F, Long E, Thompson GC, Hayes KL, Katcoff H, Cook M, Tsemberis E, Hickey CP, Williams A, Williamson-Urquhart S, Borland ML, Dalziel SR, Gelbart B, Freedman SB, Babl FE, Huang J, Kuppermann N; Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis (PRoMPT BOLUS) Investigators of the PECARN, PERC, and PREDICT Networks. PRagMatic Pediatric Trial of Balanced vs nOrmaL Saline FlUid in Sepsis: study protocol for the PRoMPT BOLUS randomized interventional trial. Trials. 2021 Nov 6;22(1):776. doi: 10.1186/s13063-021-05717-4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lactated Ringer | Other / unclassified | — | Intravenous |
| Subject | Plasmalyte | Other / unclassified | — | Intravenous |
| Comparator | sodium chloride | Unknown | — | — |
Indications
No indication recorded.