Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/13/2018 |
| Start Date: | May 23, 2017 |
| End Date: | November 2, 2017 |
Administration of intravascular (IV) fluid is the most common emergency department (ED)
procedure. IV fluids are integral to increasing effective blood volume and ensuring organ
perfusion in patients with volume depletion and dehydration. There are many options of IV
fluids providers can use when treating ED patients. Surveys show physicians do not cite an
evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to
be influenced by type and location of practice. A gap exists in the current literature, as
there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid
before discharge.
Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS
has been associated with increased risk of acidosis and acute kidney injury. This study will
use a novel approach of a patient-centered outcome in a non-critically ill population to
ascertain the optimal IV fluid for patient quality of recovery. The results of this study
will inform provider's IV fluid decisions between NS and LR. More importantly, the results of
this study will have the power to improve patient's quality of recovery following IV fluid
administration and subsequent ED discharge.
ED patients will be recruited, and participants will be randomized to receive one of two IV
solutions (Lactated ringer's or normal saline). Participants will answer a survey before and
after the intervention to assess their quality of recovery. The post-survey will be
administered by phone after ED discharge. Participants will also be contacted by text message
one week following their ED visit to gather information on their healthcare utilization.
procedure. IV fluids are integral to increasing effective blood volume and ensuring organ
perfusion in patients with volume depletion and dehydration. There are many options of IV
fluids providers can use when treating ED patients. Surveys show physicians do not cite an
evidence-based reason for selecting the crystalloid IV fluid used; the decision was likely to
be influenced by type and location of practice. A gap exists in the current literature, as
there is no evidence for the optimal IV fluid choice for the ED patient requiring IV fluid
before discharge.
Normal saline (NS) is commonly used as an IV fluid replacement in ED patients. However, NS
has been associated with increased risk of acidosis and acute kidney injury. This study will
use a novel approach of a patient-centered outcome in a non-critically ill population to
ascertain the optimal IV fluid for patient quality of recovery. The results of this study
will inform provider's IV fluid decisions between NS and LR. More importantly, the results of
this study will have the power to improve patient's quality of recovery following IV fluid
administration and subsequent ED discharge.
ED patients will be recruited, and participants will be randomized to receive one of two IV
solutions (Lactated ringer's or normal saline). Participants will answer a survey before and
after the intervention to assess their quality of recovery. The post-survey will be
administered by phone after ED discharge. Participants will also be contacted by text message
one week following their ED visit to gather information on their healthcare utilization.
This is a single-center randomized, single-blinded, controlled clinical trial testing
superiority of LR compared to NS in patients receiving IV fluid before discharge.
The study site is the University of Iowa Emergency Department (annual patient volume is
60,000 patients/year).
The study population will include adult ED patients presenting with chief complaints
associated with volume depletion. Figure 1 outlines the enrollment flowchart for the study
with inclusion and exclusion criteria. Research assistants (RAs) are available in the ED from
9am - 10pm every day, and an automated paging system will alert the team when patients
qualify, as the study team has done previously. All participants will receive 2 liters of
blinded IV fluid as part of the study. The intervention group will receive lactated ringer's,
and the control group will receive normal saline (0.9% sodium chloride). Nursing staff will
establish the peripheral IV access, and subjects will be blinded to group.
The primary outcome, Quality of Recovery-40, will be analyzed using a t-test (if parametric)
or Mann Whitney U Test (non-parametric) in an intention-to-treat (ITT) analysis. Normality
will be assessed with a Kolmogorov-Smirnov (K-S) and visualization of data. Due to the nature
of time-critical emergency department research, an additional analysis will be done by
treatment received and compared to the primary ITT analysis as a sensitivity analysis.
Secondary outcomes will be reported as a relative risk with 95%CI in an ITT analysis. A
safety analysis of secondary outcomes will be performed by treatment received (see page 37).
Baseline characteristics will be reported with summary statistics as appropriate (mean, SD,
median, IQR) and differences in characteristics will be conducted using a t-test and
chi-square test, as appropriate. The following variables will also be assessed: actual fluid
administered(mL), pre-intervention QoR-40 score, and time from intervention to primary
outcome. If differences in these characteristics exist between the control and intervention
groups, multivariate linear regression and multivariate logistic regression (primary and
secondary outcomes, respectively) will be used.
superiority of LR compared to NS in patients receiving IV fluid before discharge.
The study site is the University of Iowa Emergency Department (annual patient volume is
60,000 patients/year).
The study population will include adult ED patients presenting with chief complaints
associated with volume depletion. Figure 1 outlines the enrollment flowchart for the study
with inclusion and exclusion criteria. Research assistants (RAs) are available in the ED from
9am - 10pm every day, and an automated paging system will alert the team when patients
qualify, as the study team has done previously. All participants will receive 2 liters of
blinded IV fluid as part of the study. The intervention group will receive lactated ringer's,
and the control group will receive normal saline (0.9% sodium chloride). Nursing staff will
establish the peripheral IV access, and subjects will be blinded to group.
The primary outcome, Quality of Recovery-40, will be analyzed using a t-test (if parametric)
or Mann Whitney U Test (non-parametric) in an intention-to-treat (ITT) analysis. Normality
will be assessed with a Kolmogorov-Smirnov (K-S) and visualization of data. Due to the nature
of time-critical emergency department research, an additional analysis will be done by
treatment received and compared to the primary ITT analysis as a sensitivity analysis.
Secondary outcomes will be reported as a relative risk with 95%CI in an ITT analysis. A
safety analysis of secondary outcomes will be performed by treatment received (see page 37).
Baseline characteristics will be reported with summary statistics as appropriate (mean, SD,
median, IQR) and differences in characteristics will be conducted using a t-test and
chi-square test, as appropriate. The following variables will also be assessed: actual fluid
administered(mL), pre-intervention QoR-40 score, and time from intervention to primary
outcome. If differences in these characteristics exist between the control and intervention
groups, multivariate linear regression and multivariate logistic regression (primary and
secondary outcomes, respectively) will be used.
Inclusion Criteria:
- Emergency department patient
- Chief complaint of nausea, vomiting or emesis, diarrhea, abdominal pain, dehydration,
heat stroke or exhaustion
- ED provider approves administration of two liters of fluid
- ED provider states patient is likely to be discharged
- Patient has followed up with PCP in the last two years
- Patient has access to phone for next two days following ED discharge
Exclusion Criteria:
- Prisoners
- Children
- Women known to be pregnant
- Jaundice
- Current chemotherapy
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University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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