Trial Outcomes & Findings for Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach (NCT NCT02135146)
NCT ID: NCT02135146
Last Updated: 2020-03-03
Results Overview
Acute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI. (1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase \> two- to threefold from baseline. (3) Increase \> threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Post-op up to 72 hours
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
Plasmalyte 3ml/kg/hr Group
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
Baseline characteristics by cohort
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.2 years
STANDARD_DEVIATION 9.2 • n=99 Participants
|
65.1 years
STANDARD_DEVIATION 12.1 • n=107 Participants
|
63.6 years
STANDARD_DEVIATION 10.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
ASA Score
ASA 2
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
ASA Score
ASA 3
|
11 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Body Weight
|
58.8 kg
STANDARD_DEVIATION 10.9 • n=99 Participants
|
65.2 kg
STANDARD_DEVIATION 12.1 • n=107 Participants
|
62.02 kg
STANDARD_DEVIATION 11.9 • n=206 Participants
|
|
Ideal Body Weight
|
57.9 kg
STANDARD_DEVIATION 8.5 • n=99 Participants
|
57.16 kg
STANDARD_DEVIATION 5.5 • n=107 Participants
|
57.5 kg
STANDARD_DEVIATION 7.1 • n=206 Participants
|
|
Height
|
165.1 cm
STANDARD_DEVIATION 7.9 • n=99 Participants
|
165 cm
STANDARD_DEVIATION 5.9 • n=107 Participants
|
165.05 cm
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
BMI
|
21.5 kg/m2
STANDARD_DEVIATION 3.2 • n=99 Participants
|
24.1 kg/m2
STANDARD_DEVIATION 4.9 • n=107 Participants
|
22.8 kg/m2
STANDARD_DEVIATION 4.3 • n=206 Participants
|
|
Epidural
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Smoker
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Chronic Obstructive Pulmonary Disease (COPD)
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Asthma
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Pulmonary Hypertension
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Coronary Artery Disease (CAD)
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Hypertension (HTN)
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Heart Disease
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Peripheral Vascular Disease (PVD)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Diabetes
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Hepatitis
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Chronic Kidney Disease (CKD)
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Seizure
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Lung Cancer
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Chronic Lung Infection
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Surgical Procedure (Video-Assisted Thoracoscopic Surgery-VATS)
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Procedure Duration
|
162.1 min
STANDARD_DEVIATION 75.1 • n=99 Participants
|
153.4 min
STANDARD_DEVIATION 62.7 • n=107 Participants
|
157.8 min
STANDARD_DEVIATION 68.5 • n=206 Participants
|
|
Anesthesia Duration
|
206.6 min
STANDARD_DEVIATION 79.4 • n=99 Participants
|
198.9 min
STANDARD_DEVIATION 67.4 • n=107 Participants
|
202.7 min
STANDARD_DEVIATION 72.8 • n=206 Participants
|
|
Creatinine
|
0.86 mg/dL
STANDARD_DEVIATION 0.22 • n=99 Participants
|
0.84 mg/dL
STANDARD_DEVIATION 0.17 • n=107 Participants
|
0.85 mg/dL
STANDARD_DEVIATION 0.195 • n=206 Participants
|
PRIMARY outcome
Timeframe: Post-op up to 72 hoursAcute renal injury as defined by the American Kidney Injury Network (AKIN) criteria in the first 72 hours postoperatively (serum creatinine levels). The AKIN scale will be used to assess the presence and severity of acute kidney injury (AKI). The AKIN is a classification/staging system of acute kidney injury developed by the Acute Kidney Injury Network which uses changes in serum creatinine (SCr) and urine output to assess AKI. Stages of acute kidney injury are defined as 1, 2, or 3, with 3 indicating the most severe AKI. (1) Increase ≥ 0.3 mg per dL (26.52 μmol per L) or ≥ 1.5- to twofold from baseline. (2) Increase \> two- to threefold from baseline. (3) Increase \> threefold from baseline or ≥ 4.0 mg per dL (353.60 μmol per L) with an acute rise of at least 0.5 mg per dL (44.20 μmol per L).
Outcome measures
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Development of Renal Injury
|
0.8 mg/dL
Standard Deviation 0.25
|
0.74 mg/dL
Standard Deviation 0.14
|
PRIMARY outcome
Timeframe: Post-op up to 72 hoursThe number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.
Outcome measures
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Development of Pulmonary Edema
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 7 daysLength of Surgical Intensive Unit Stay/Hospital Stay
Outcome measures
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Length of Surgical Intensive Unit Stay/Hospital Stay
|
0.6 days
Standard Deviation 1.5
|
0.2 days
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Post-op up to 48 hoursTime to removal of Chest Tubes
Outcome measures
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Removal of Chest Tubes
|
3.5 minutes
Standard Deviation 2.5
|
3.7 minutes
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: Up to 7 daysDevelopment of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Outcome measures
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Development of Morbidity
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Assessed up to 30 days Post-opPopulation: Missing participants lost to follow-up.
Death
Outcome measures
| Measure |
Plasmalyte 3ml/kg/hr Group
n=9 Participants
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=11 Participants
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Death
|
0 Participants
|
0 Participants
|
Adverse Events
Plasmalyte 3ml/kg/hr Group
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Plasmalyte 6ml/kg/hr Group
Serious events: 5 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Plasmalyte 3ml/kg/hr Group
n=20 participants at risk
Plasmalyte 3ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
|
Plasmalyte 6ml/kg/hr Group
n=20 participants at risk
Plasmalyte 6ml/kg/hr group: This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
20.0%
4/20 • Number of events 4
|
15.0%
3/20 • Number of events 3
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia (SVT)
|
0.00%
0/20
|
5.0%
1/20 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Nick Naughton, Professional Research Assistant
University of Colorado
Phone: 3037200833
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place