NCT02950753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2017

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

January 4, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

April 12, 2019

Completed
Last Updated

April 12, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

October 26, 2016

Results QC Date

June 13, 2018

Last Update Submit

January 14, 2019

Conditions

Hyperlactatemia

Keywords

Elevated Serum LactateSerum lactateRinger's LactateLactated Ringer'sHyperlactatemia

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Lactate Level of the LR Group Compared to the NS Group.

    Final mean lactate minus initial mean lactate

    5 minutes after IV bolus has ended.

Secondary Outcomes (2)

  • Decrease in Bicarbonate Level of the LR Group Compared to the NS Group

    5 minutes after IV bolus has ended.

  • Final Chloride Level Minus Initial Chloride Level of the LR Group Compared to the NS Group

    5 minutes after IV bolus has ended.

Study Arms (2)

Lactated Ringer

EXPERIMENTAL

Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.

Drug: Lactated Ringer Solution

Normal Saline

PLACEBO COMPARATOR

Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.

Drug: Normal Saline

Interventions

Lactated Ringer SolutionDRUG

Fluid bolus of Lactated Ringer solution (30ml/kg).

Also known as: LR
Lactated Ringer
Normal SalineDRUG

Fluid bolus or Normal Saline (30ml/kg).

Also known as: NS
Normal Saline

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult volunteers
  • years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Related Publications (8)

  • Zitek T, Cleveland N, Rahbar A, Parker J, Lim C, Elsbecker S, Forred W, Slattery DE. Effect of Nebulized Albuterol on Serum Lactate and Potassium in Healthy Subjects. Acad Emerg Med. 2016 Jun;23(6):718-21. doi: 10.1111/acem.12937. Epub 2016 May 11.

    PMID: 26857949BACKGROUND

  • Kellum JA. Fluid resuscitation and hyperchloremic acidosis in experimental sepsis: improved short-term survival and acid-base balance with Hextend compared with saline. Crit Care Med. 2002 Feb;30(2):300-5. doi: 10.1097/00003246-200202000-00006.

    PMID: 11889298BACKGROUND

  • Rivers E, Nguyen B, Havstad S, Ressler J, Muzzin A, Knoblich B, Peterson E, Tomlanovich M; Early Goal-Directed Therapy Collaborative Group. Early goal-directed therapy in the treatment of severe sepsis and septic shock. N Engl J Med. 2001 Nov 8;345(19):1368-77. doi: 10.1056/NEJMoa010307.

    PMID: 11794169RESULT

  • Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

    PMID: 23353941RESULT

  • ProCESS Investigators; Yealy DM, Kellum JA, Huang DT, Barnato AE, Weissfeld LA, Pike F, Terndrup T, Wang HE, Hou PC, LoVecchio F, Filbin MR, Shapiro NI, Angus DC. A randomized trial of protocol-based care for early septic shock. N Engl J Med. 2014 May 1;370(18):1683-93. doi: 10.1056/NEJMoa1401602. Epub 2014 Mar 18.

    PMID: 24635773RESULT

  • Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 2015 Apr 2;372(14):1301-11. doi: 10.1056/NEJMoa1500896. Epub 2015 Mar 17.

    PMID: 25776532RESULT

  • ARISE Investigators; ANZICS Clinical Trials Group; Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 2014 Oct 16;371(16):1496-506. doi: 10.1056/NEJMoa1404380. Epub 2014 Oct 1.

    PMID: 25272316RESULT

  • Didwania A, Miller J, Kassel D, Jackson EV Jr, Chernow B. Effect of intravenous lactated Ringer's solution infusion on the circulating lactate concentration: Part 3. Results of a prospective, randomized, double-blind, placebo-controlled trial. Crit Care Med. 1997 Nov;25(11):1851-4. doi: 10.1097/00003246-199711000-00024.

    PMID: 9366769RESULT

MeSH Terms

Conditions

Hyperlactatemia

Interventions

Ringer's LactateSaline Solution

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Results Point of Contact

Title
Dr. Tony Zitek
Organization
UMCSouthernNevada
zitek10@gmail.com
702-383-7885

Study Officials

  • Joseph A Zitek, MD

    University Medical Center of Southern Nevada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

October 26, 2016

First Posted

November 1, 2016

Study Start

January 4, 2017

Primary Completion

May 5, 2017

Study Completion

June 1, 2017

Last Updated

April 12, 2019

Results First Posted

April 12, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Identifiable Patient Data (IPD) will not be shared

Locations

US(1)