Clinical Trial: Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate?

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate?

Brief 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.

Detailed Summary:

Methods:

Approximately 30 subjects will be randomized to either the Lactated Ringer's group or the Placebo group. The study is powered to detect a difference of 0.3mmol/L between pre- and post-treatment lactate levels. All subjects are healthy volunteers over 18 years old. Healthy volunteers are defined as subjects with no acute symptoms who do not meet any of the exclusionary criteria below:

  • Pregnancy or currently breast-feeding
  • Prisoner status
  • Those with any history of clinical conditions associated with fluid overload: congestive heart failure, renal, or hepatic failure
  • Baseline serum lactate level >2.2mmol
  • Baseline creatinine > 1.5 mg/dL

All volunteers will sign a written consent, approved by the Institutional Review Board (IRB). The consent form will discuss the risks and benefits of our study. The benefit of our study is to identify a possible confounder to our current interpretation of serum lactates. By clarifying whether Lactated Ringer's fluid can contribute to measured serum lactate level we hope to improve our care to septic patients and those patients with abnormal vital signs and elevated serum lactate levels in whom the diagnosis of sepsis is being considered. The risks of this study include the possible development of fluid overload state and pulmonary edema. We believe these sequelae would be very unlikely to occur since we are excluding anyone with a history of any clinical conditions associated with fluid overload.

The intended pool of our volunteer subjects will be from residents, attendings, hospital staff, and medical stu
Sponsor: University Medical Center of Southern Nevada

Current Primary Outcome: Change in lactate level of the LR group compared to the NS group. [ Time Frame: 5 minutes after IV bolus has ended. ]

Baseline serum lactate will be measured just prior to IV administration and again at 5 minutes after IV bolus has ended.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in bicarbonate level of the LR group compared to the NS group [ Time Frame: 5 minutes after IV bolus has ended. ]
    Baseline serum bicarbonate will be measured in both groups just prior to IV administration and again at 5 minutes after IV bolus has ended.
  • Change in chloride level of the LR group compared to the NS group [ Time Frame: 5 minutes after IV bolus has ended. ]
    Baseline serum chloride will be measured in both groups just prior to IV administration and again at 5 minutes after IV bolus has ended.


Original Secondary Outcome: Same as current

Information By: University Medical Center of Southern Nevada

Dates:
Date Received: October 26, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: October 27, 2016
Last Verified: October 2016