Hypotension, Kidney Injury
Conditions
Keywords
Hypotension, Kidney injury
Brief summary
The purpose of this study is to conduct a prospective, randomized, controlled trial comparing a restrictive vs. conservative fluid strategy in thoracic surgery patients. Excessive perioperative fluid has been retrospectively implicated in the development postoperative acute lung injury (PALI) and pulmonary edema following lung resection. However, fluid restriction in these patients is not without risk and may compromise end organ perfusion (i.e. acute kidney injury). The hypothesis is that a conservative fluid approach in thoracic surgery patients will result in better end organ perfusion with fewer occasions of acute kidney injury (AKI) without causing an increase in postoperative acute lung injury or pulmonary edema.
Interventions
DRUGPlasmalyte 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
DRUGPlasmalyte 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
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* between 18-89 years of age * undergoing pulmonary lobectomy with open or video assisted thoracotomy
Exclusion criteria
* patient refusal * pregnancy * cardiac arrhythmia * pacemaker dependency * severe aortic insufficiency * idiopathic hypertrophic subaortic stenosis * prisoners * decisionally challenged * patients that refuse to receive intravenous fluid products made from human plasma (Albumin 5%) * patients with skin infection or breakdown on their fingers * severe peripheral vascular disease * evidence of compromised finger perfusion will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of Renal Injury | Post-op up to 72 hours | 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). |
| Development of Pulmonary Edema | Post-op up to 72 hours | The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Surgical Intensive Unit Stay/Hospital Stay | Up to 7 days | Length of Surgical Intensive Unit Stay/Hospital Stay |
| Removal of Chest Tubes | Post-op up to 48 hours | Time to removal of Chest Tubes |
| Development of Morbidity | Up to 7 days | Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium |
| Death | Assessed up to 30 days Post-op | Death |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Total | Plasmalyte 6ml/kg/hr Group | Plasmalyte 3ml/kg/hr Group |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 10.6 | 65.1 years STANDARD_DEVIATION 12.1 | 62.2 years STANDARD_DEVIATION 9.2 |
| Anesthesia Duration | 202.7 min STANDARD_DEVIATION 72.8 | 198.9 min STANDARD_DEVIATION 67.4 | 206.6 min STANDARD_DEVIATION 79.4 |
| ASA Score ASA 2 | 14 Participants | 5 Participants | 9 Participants |
| ASA Score ASA 3 | 26 Participants | 15 Participants | 11 Participants |
| Asthma | 5 Participants | 2 Participants | 3 Participants |
| BMI | 22.8 kg/m2 STANDARD_DEVIATION 4.3 | 24.1 kg/m2 STANDARD_DEVIATION 4.9 | 21.5 kg/m2 STANDARD_DEVIATION 3.2 |
| Body Weight | 62.02 kg STANDARD_DEVIATION 11.9 | 65.2 kg STANDARD_DEVIATION 12.1 | 58.8 kg STANDARD_DEVIATION 10.9 |
| Chronic Kidney Disease (CKD) | 0 Participants | 0 Participants | 0 Participants |
| Chronic Lung Infection | 28 Participants | 13 Participants | 15 Participants |
| Chronic Obstructive Pulmonary Disease (COPD) | 5 Participants | 0 Participants | 5 Participants |
| Coronary Artery Disease (CAD) | 2 Participants | 1 Participants | 1 Participants |
| Creatinine | 0.85 mg/dL STANDARD_DEVIATION 0.195 | 0.84 mg/dL STANDARD_DEVIATION 0.17 | 0.86 mg/dL STANDARD_DEVIATION 0.22 |
| Diabetes | 3 Participants | 0 Participants | 3 Participants |
| Epidural | 7 Participants | 3 Participants | 4 Participants |
| Heart Disease | 1 Participants | 1 Participants | 0 Participants |
| Height | 165.05 cm STANDARD_DEVIATION 6.8 | 165 cm STANDARD_DEVIATION 5.9 | 165.1 cm STANDARD_DEVIATION 7.9 |
| Hepatitis | 3 Participants | 0 Participants | 3 Participants |
| Hypertension (HTN) | 10 Participants | 4 Participants | 6 Participants |
| Ideal Body Weight | 57.5 kg STANDARD_DEVIATION 7.1 | 57.16 kg STANDARD_DEVIATION 5.5 | 57.9 kg STANDARD_DEVIATION 8.5 |
| Lung Cancer | 12 Participants | 7 Participants | 5 Participants |
| Peripheral Vascular Disease (PVD) | 0 Participants | 0 Participants | 0 Participants |
| Procedure Duration | 157.8 min STANDARD_DEVIATION 68.5 | 153.4 min STANDARD_DEVIATION 62.7 | 162.1 min STANDARD_DEVIATION 75.1 |
| Pulmonary Hypertension | 0 Participants | 0 Participants | 0 Participants |
| Seizure | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Female | 35 Participants | 19 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 1 Participants | 4 Participants |
| Smoker | 18 Participants | 9 Participants | 9 Participants |
| Surgical Procedure (Video-Assisted Thoracoscopic Surgery-VATS) | 37 Participants | 19 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 4 / 20 | 5 / 20 |
Outcome results
Primary
Development of Pulmonary Edema
The number of participants diagnosed with mild to severe pulmonary edema at any time up to 72 hours after surgery is reported.
Time frame: Post-op up to 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasmalyte 3ml/kg/hr Group | Development of Pulmonary Edema | 4 Participants |
| Plasmalyte 6ml/kg/hr Group | Development of Pulmonary Edema | 3 Participants |
Primary
Development of Renal Injury
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).
Time frame: Post-op up to 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plasmalyte 3ml/kg/hr Group | Development of Renal Injury | 0.8 mg/dL | Standard Deviation 0.25 |
| Plasmalyte 6ml/kg/hr Group | Development of Renal Injury | 0.74 mg/dL | Standard Deviation 0.14 |
p-value: 0.31t-test, 2 sided
p-value: 0.07t-test, 2 sided
Secondary
Death
Death
Time frame: Assessed up to 30 days Post-op
Population: Missing participants lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasmalyte 3ml/kg/hr Group | Death | 0 Participants |
| Plasmalyte 6ml/kg/hr Group | Death | 0 Participants |
Secondary
Development of Morbidity
Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Time frame: Up to 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plasmalyte 3ml/kg/hr Group | Development of Morbidity | 4 Participants |
| Plasmalyte 6ml/kg/hr Group | Development of Morbidity | 5 Participants |
Secondary
Length of Surgical Intensive Unit Stay/Hospital Stay
Length of Surgical Intensive Unit Stay/Hospital Stay
Time frame: Up to 7 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plasmalyte 3ml/kg/hr Group | Length of Surgical Intensive Unit Stay/Hospital Stay | 0.6 days | Standard Deviation 1.5 |
| Plasmalyte 6ml/kg/hr Group | Length of Surgical Intensive Unit Stay/Hospital Stay | 0.2 days | Standard Deviation 0.7 |
Secondary
Removal of Chest Tubes
Time to removal of Chest Tubes
Time frame: Post-op up to 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Plasmalyte 3ml/kg/hr Group | Removal of Chest Tubes | 3.5 minutes | Standard Deviation 2.5 |
| Plasmalyte 6ml/kg/hr Group | Removal of Chest Tubes | 3.7 minutes | Standard Deviation 3.9 |