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NCT03537898: BASE
Balanced Solutions and Plasma Electrolytes
NA trial testing Lactated Ringer's in Critical Illness in 2,093 participants. Completed in 2 March 2019.
7 February 2019
Quick facts
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 2,093 |
| Start date | 1 June 2018 |
| Primary completion | 7 February 2019 |
| Estimated completion | 2 March 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lactated Ringer's
- Normosol
Conditions studied
- Critical Illness — all drugs for Critical Illness →
- Acidosis, Metabolic — all drugs for Acidosis, Metabolic →
Sponsor
Vanderbilt University Medical Center
Who can join
18 and older, any sex, with Critical Illness or Acidosis, Metabolic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent prospective, randomized trials have shown improved patient outcomes with the use of balanced crystalloids compared to saline. There have not been large randomized studies comparing acetate buffered balanced crystalloids to non-acetate buffered balanced crystalloids in the critically ill. BASE will be a pilot study for a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the Medical ICU at Vanderbilt University from June 2018 until January 2019. The primary endpoint will be plasma bicarbonate concentration between Intensive Care Unit admission and hospital discharge.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Balanced Crystalloid Solutions.
Semler MW, Kellum JA. · · 2019 · cited 98× · PMID 30407838 · DOI 10.1164/rccm.201809-1677ci -
Comparison of Balanced Crystalloid Solutions: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Curran JD, Major P, Tang K, Bagshaw SM, et al · · 2021 · cited 16× · PMID 34036269 · DOI 10.1097/cce.0000000000000398 -
Acetate- versus lactate-buffered crystalloid solutions: A systematic review with meta-analysis and trial sequential analysis.
Ellekjaer KL, Perner A, Sivapalan P, Møller MH. · · 2022 · cited 6× · PMID 35488485 · DOI 10.1111/aas.14076 -
Normosol-R vs Lactated Ringers in the Critically Ill: A Randomized Trial.
Qian ET, Brown RM, Jackson KE, Wang L, et al · · 2025 · cited 1× · PMID 39971001 · DOI 10.1016/j.chest.2025.02.008
Verify or expand the search:
- PubMed search for NCT03537898
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03537898 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vanderbilt University Medical Center
- Last refreshed: 11 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03537898.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing