Trial Outcomes & Findings for Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables (NCT NCT03054922)
NCT ID: NCT03054922
Last Updated: 2020-03-25
Results Overview
Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
59 participants
Primary outcome timeframe
During surgery (typically 4-6 hrs in length)
Results posted on
2020-03-25
Participant Flow
Participant milestones
| Measure |
Normal Saline
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
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 |
Normal Saline
n=20 Participants
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
n=19 Participants
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
n=20 Participants
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14 years
STANDARD_DEVIATION 3 • n=20 Participants
|
14 years
STANDARD_DEVIATION 2 • n=19 Participants
|
14 years
STANDARD_DEVIATION 2 • n=20 Participants
|
14 years
STANDARD_DEVIATION 2 • n=59 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
10 Participants
n=19 Participants
|
14 Participants
n=20 Participants
|
41 Participants
n=59 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
9 Participants
n=19 Participants
|
6 Participants
n=20 Participants
|
18 Participants
n=59 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
19 participants
n=19 Participants
|
20 participants
n=20 Participants
|
59 participants
n=59 Participants
|
|
Weight
|
61 kilograms
STANDARD_DEVIATION 13 • n=20 Participants
|
57 kilograms
STANDARD_DEVIATION 19 • n=19 Participants
|
57 kilograms
STANDARD_DEVIATION 18 • n=20 Participants
|
58 kilograms
STANDARD_DEVIATION 17 • n=59 Participants
|
PRIMARY outcome
Timeframe: During surgery (typically 4-6 hrs in length)Change in base deficit from 1st to 2nd blood gas to measure metabolic acidosis
Outcome measures
| Measure |
Normal Saline
n=20 Participants
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
n=19 Participants
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
n=20 Participants
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
|---|---|---|---|
|
Change in Base Deficit
|
-1.5 mEq/L
Standard Deviation 2.4
|
-1.2 mEq/L
Standard Deviation 2.3
|
-0.5 mEq/L
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: During surgery (typically 4-6 hrs in length)Change in sodium electrolyte from 1st to 2nd blood gas
Outcome measures
| Measure |
Normal Saline
n=20 Participants
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
n=19 Participants
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
n=20 Participants
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
|---|---|---|---|
|
Change in Sodium
|
0.1 mEq/L
Standard Deviation 1.7
|
-0.4 mEq/L
Standard Deviation 1.5
|
-0.1 mEq/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: During surgery (typically 4-6 hrs in length)Change in potassium electrolyte from 1st to 2nd blood gas
Outcome measures
| Measure |
Normal Saline
n=20 Participants
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
n=19 Participants
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
n=20 Participants
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
|---|---|---|---|
|
Change in Potassium
|
0.4 mEq/L
Standard Deviation 0.4
|
0.7 mEq/L
Standard Deviation 0.6
|
0.2 mEq/L
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: During surgery (typically 4-6 hrs in length)Change in calcium electrolyte from 1st to 2nd blood gas
Outcome measures
| Measure |
Normal Saline
n=20 Participants
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
n=19 Participants
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
n=20 Participants
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
|---|---|---|---|
|
Change in Ionized Calcium
|
0.01 mEq/L
Standard Deviation 0.05
|
-0.13 mEq/L
Standard Deviation 0.57
|
-0.01 mEq/L
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: During surgery (typically 4-6 hrs in length)Change in pH from 1st to 2nd blood gas
Outcome measures
| Measure |
Normal Saline
n=20 Participants
0.9% Sodium Chloride
Normal Saline: IV infusion of 0.9% NaCl throughout surgery.
|
Lactated Ringers
n=19 Participants
Each 100 mL of Lactated Ringer's Injection USP contains:
Sodium Chloride USP 0.6 g; Sodium Lactate USP 0.31 g; Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g; Water for Injection USP qs
Lactated Ringer: IV infusion of lactated ringer throughout surgery.
|
Normosol-R
n=20 Participants
Each 100 mL of Normosol-R contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride hexahydrate, 30 mg.
Normosol-R Inj: IV infusion of Normosol throughout surgery.
|
|---|---|---|---|
|
Change in pH
|
-0.03 units on a scale
Standard Deviation 0.04
|
-0.02 units on a scale
Standard Deviation 0.06
|
0.01 units on a scale
Standard Deviation 0.06
|
Adverse Events
Normal Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lactated Ringers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normosol-R
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