Early Phase 1 N=30 Randomized Quadruple-blind Diagnostic

Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate?

Hyperlactatemia

Bottom Line

View on ClinicalTrials.gov: NCT02950753 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2019

Primary outcome: Primary: Change in Mean Lactate Level of the LR Group Compared to the NS Group. — 0.93; 0.37 mmol/L

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Lactated Ringer Solution (Drug); Normal Saline (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University Medical Center of Southern Nevada
Primary completion: May 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Lactate Level of the LR Group Compared to the NS Group.	0.93; 0.37	—
SECONDARY Decrease in Bicarbonate Level of the LR Group Compared to the NS Group	-0.36; 2.35	—
SECONDARY Final Chloride Level Minus Initial Chloride Level of the LR Group Compared to the NS Group	-0.4; 3.7	—

Summary

Lactated Ringer's (LR) solution bolus is commonly administered in the emergency department setting to seriously ill patients. It is also common to obtain blood samples to determine serum lactate levels to aid in the assessment of the patient's degree of illness. This study endeavors to determine if serum lactate levels are affected by LR fluid administration in healthy adult individuals as compared to those who receive Normal Saline (NS). Healthy adult volunteers will be used as subjects so that the illness of hospital patients does not confound the results.

Eligibility Criteria

Inclusion Criteria

Healthy adult volunteers
18 years and older

Exclusion Criteria

Pregnancy or currently breast-feeding
Prisoner
History of conditions associated with fluid overload: heart, renal or hepatic failure
Baseline serum lactate level >2.2mmol
Baseline creatinine > 1.5 mg/dL

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02950753). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.