Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
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ClinicalTrials.gov Identifier: NCT02135146 |
Recruitment Status :
Completed
First Posted : May 9, 2014
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypotension Kidney Injury | Drug: Plasmalyte 3ml/kg/hr group Drug: Plasmalyte 6ml/kg/hr group | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Plasmalyte 3ml/kg/hr group |
Drug: 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 |
Active Comparator: Plasmalyte 6ml/kg/hr group |
Drug: 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 [ Time Frame: 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 [ Time Frame: 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.
- Length of Surgical Intensive Unit Stay/Hospital Stay [ Time Frame: Up to 7 days ]Length of Surgical Intensive Unit Stay/Hospital Stay
- Removal of Chest Tubes [ Time Frame: Post-op up to 48 hours ]Time to removal of Chest Tubes
- Development of Morbidity [ Time Frame: Up to 7 days ]Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
- Death [ Time Frame: Assessed up to 30 days Post-op ]Death

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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135146
United States, Colorado | |
University of Colorado Hospital | |
Aurora, Colorado, United States, 80138 |
Principal Investigator: | Tamas Seres, M.D., PH.D. | University of Colorado, Denver |
Responsible Party: | University of Colorado, Denver |
ClinicalTrials.gov Identifier: | NCT02135146 |
Other Study ID Numbers: |
13-1900 13-1900 ( Other Identifier: COMIRB ) |
First Posted: | May 9, 2014 Key Record Dates |
Results First Posted: | March 3, 2020 |
Last Update Posted: | March 3, 2020 |
Last Verified: | February 2020 |
Hypotension Kidney injury |
Hypotension Vascular Diseases Cardiovascular Diseases |
Plasma-lyte 148 Ophthalmic Solutions Pharmaceutical Solutions |