Trial Outcomes & Findings for Does Intravenous Lactated Ringer Solution Raise Measured Serum Lactate? (NCT NCT02950753)
NCT ID: NCT02950753
Last Updated: 2019-04-12
Results Overview
Final mean lactate minus initial mean lactate
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
30 participants
Primary outcome timeframe
5 minutes after IV bolus has ended.
Results posted on
2019-04-12
Participant Flow
Participant milestones
| Measure |
Lactated Ringer
Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.
Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg).
|
Normal Saline
Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.
Normal Saline: Fluid bolus or Normal Saline (30ml/kg).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lactated Ringer
n=15 Participants
Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.
Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg).
|
Normal Saline
n=15 Participants
Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.
Normal Saline: Fluid bolus or Normal Saline (30ml/kg).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=15 Participants
|
15 Participants
n=15 Participants
|
30 Participants
n=30 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=15 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=15 Participants
|
8 Participants
n=15 Participants
|
11 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=15 Participants
|
7 Participants
n=15 Participants
|
19 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
15 participants
n=15 Participants
|
15 participants
n=15 Participants
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: 5 minutes after IV bolus has ended.Final mean lactate minus initial mean lactate
Outcome measures
| Measure |
Lactated Ringer
n=15 Participants
Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.
Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg).
|
Normal Saline
n=15 Participants
Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.
Normal Saline: Fluid bolus or Normal Saline (30ml/kg).
|
|---|---|---|
|
Change in Mean Lactate Level of the LR Group Compared to the NS Group.
|
0.93 mmol/L
Interval 0.42 to 1.44
|
0.37 mmol/L
Interval -0.26 to 1.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lactated Ringer
n=15 Participants
Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.
Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg).
|
Normal Saline
n=15 Participants
Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.
Normal Saline: Fluid bolus or Normal Saline (30ml/kg).
|
|---|---|---|
|
Decrease in Bicarbonate Level of the LR Group Compared to the NS Group
|
-0.36 mEq/L
Standard Deviation 2.6
|
2.35 mEq/L
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Lactated Ringer
n=15 Participants
Intravenous bolus of Lactated Ringer solution (30ml/kg) via 18ga IV catheter at wide open.
Lactated Ringer Solution: Fluid bolus of Lactated Ringer solution (30ml/kg).
|
Normal Saline
n=15 Participants
Intravenous bolus of Normal Saline (30ml/kg) via 18ga IV catheter at wide open.
Normal Saline: Fluid bolus or Normal Saline (30ml/kg).
|
|---|---|---|
|
Final Chloride Level Minus Initial Chloride Level of the LR Group Compared to the NS Group
|
-0.4 mEq/L
Standard Deviation 2.4
|
3.7 mEq/L
Standard Deviation 1.4
|
Adverse Events
Lactated Ringer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place