Trial Outcomes & Findings for Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation (NCT NCT03133767)

Last Updated: 2018-09-11

Results Overview

The Quality of Recovery-40 (QoR-40) is a validated instrument that quantifies patient's self-assessment of functional recovery, symptoms, and physical comfort. The QoR-40 scores range from 40 to 200 with a 200 representing a better recovery outcome. The survey consists of 40 questions scored from one to five with a Likert scale, and the total score is the sum of each question.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

157 participants

Primary outcome timeframe

24 hours after ED visit

Results posted on

2018-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Lactated Ringers Solution Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV	Normal Saline Solution Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV
Overall Study STARTED	79	78
Overall Study COMPLETED	41	53
Overall Study NOT COMPLETED	38	25

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactated Ringers Solution Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV	Normal Saline Solution Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV
Overall Study Lost to Follow-up	38	24
Overall Study Protocol Violation	0	1

Baseline Characteristics

Saline vs. Lactated Ringers for Emergency Department IV Fluid Resuscitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactated Ringers Solution n=41 Participants Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV	Normal Saline Solution n=53 Participants Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV	Total n=94 Participants Total of all reporting groups
Age, Continuous	29 years n=93 Participants	39 years n=4 Participants	35 years n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	24 Participants n=4 Participants	58 Participants n=27 Participants
Sex: Female, Male Male	7 Participants n=93 Participants	29 Participants n=4 Participants	36 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	0 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	7 Participants n=4 Participants	9 Participants n=27 Participants
Race (NIH/OMB) White	34 Participants n=93 Participants	45 Participants n=4 Participants	79 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants	1 Participants n=4 Participants	3 Participants n=27 Participants
Region of Enrollment United States	41 participants n=93 Participants	53 participants n=4 Participants	94 participants n=27 Participants

PRIMARY outcome

Timeframe: 24 hours after ED visit

Outcome measures

Outcome measures
Measure	Normal Saline Solution n=53 Participants Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV	Lactated Ringers Solution n=41 Participants Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV
Quality of Recovery-40 Score at 24 Hours	164.4 units on a scale Interval 157.8 to 171.0	166.8 units on a scale Interval 160.5 to 173.1

SECONDARY outcome

Timeframe: Immediately after fluid administration

Outcome measures

Outcome measures
Measure	Normal Saline Solution n=53 Participants Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV	Lactated Ringers Solution n=41 Participants Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV
Quality of Recovery-40 Score After Administration	141.6 units on a scale Interval 133.5 to 149.7	152.6 units on a scale Interval 145.3 to 159.9

SECONDARY outcome

Timeframe: 7 days after study enrollment

Population: Only participants that received an ED prescription and responded to the seven-day text message were included in this analysis (26 participants in the LR and 25 in the NS group).

Seven days after study enrollment, participants were asked by text message, "Have you filled any prescriptions from the emergency department?"

Outcome measures

Outcome measures
Measure	Normal Saline Solution n=25 Participants Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV	Lactated Ringers Solution n=26 Participants Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV
Number of Participants That Filled an ED Prescription	19 Participants	14 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Response rates for the secondary outcomes were 47.4% (n=36) in the NS group and 53.3% (n=42) in the LR group.

Seven days after study enrollment, participants were asked by text message, "Have you returned to the emergency department for the same problem?"

Outcome measures

Outcome measures
Measure	Normal Saline Solution n=36 Participants Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV	Lactated Ringers Solution n=42 Participants Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV
Number of Participants That Returned to the ED Within 7 Days for the Same Complaint	7 Participants	5 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Response rates for the secondary outcomes were 47.4% (n=36) in the NS group and 53.3% (n=42) in the LR group.

Seven days after study enrollment, participants were asked by text message, "Have you seen another medical provider for the same complaint?".

Outcome measures

Outcome measures
Measure	Normal Saline Solution n=36 Participants Participants in this arm will receive two liters of IV 0.9% sodium chloride solution during their emergency department stay Normal Saline 0.9% Infusion Solution Bag: 2 liters of intravenous normal saline solution will be administered by peripheral IV	Lactated Ringers Solution n=42 Participants Participants in this arm will receive two liters of IV Lactated Ringer's solution during their emergency department stay Lactated Ringer Solution: 2 liters of intravenous lactated ringers solution will be administered by peripheral IV
Participants That Sought Care From Another Healthcare Provider for the Same Complaint	7 Participants	9 Participants

Adverse Events

Lactated Ringers Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nicholas Mohr

University of Iowa

Phone: 319-384-8285

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place