HypotensionPhase 4NCT02135146
Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
A Phase 4 study testing Plasmalyte 3ml/kg/hr group and Plasmalyte 6ml/kg/hr group in people with Hypotension and Kidney Injury, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hypotension, Kidney Injury
- What is being tested?
- Plasmalyte 3ml/kg/hr group and Plasmalyte 6ml/kg/hr group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18-89 years of age
- undergoing pulmonary lobectomy with open or video assisted thoracotomy
Who cannot join
- patient refusal
- pregnancy
- cardiac arrhythmia
- pacemaker dependency
- severe aortic insufficiency
- idiopathic hypertrophic subaortic stenosis
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80138
About this study
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.
- Conditions
- Hypotension, Kidney Injury
- Being tested
- Plasmalyte 3ml/kg/hr group, Plasmalyte 6ml/kg/hr group
- Keywords
- Hypotension, Kidney injury
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmalyte 3ml/kg/hr groupDrug
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 groupDrug
This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
| Study group | Role | What they receive |
|---|---|---|
| Plasmalyte 3ml/kg/hr group | Active comparator | Not described Receives: Drug: Plasmalyte 3ml/kg/hr group |
| Plasmalyte 6ml/kg/hr group | Active comparator | Not described Receives: Drug: Plasmalyte 6ml/kg/hr group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Post-op up to 72 hours
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.
Measured: Post-op up to 72 hours
Secondary outcomes (4)
Length of Surgical Intensive Unit Stay/Hospital Stay
Length of Surgical Intensive Unit Stay/Hospital Stay
Measured: Up to 7 days
Removal of Chest Tubes
Time to removal of Chest Tubes
Measured: Post-op up to 48 hours
Development of Morbidity
Development of Morbidity, including: acute lung injury, Acute Respiratory Distress, Deep Vein Thrombus, infection, delirium
Measured: Up to 7 days
Death
Death
Measured: Assessed up to 30 days Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamas Seres, M.D., PH.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02135146
- Sponsor's protocol ID
- 13-1900
- Other IDs
- 13-1900
- Status last verified
- Feb 2020
- First submitted
- 6 May 2014
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Fluid Strategies in Thoracic Surgery Patients Utilizing a Goal Directed Approach
- ClinicalTrials.gov ID
- NCT02135146
- Acronym / sponsor ID
- 13-1900
- Conditions
- Hypotension, Kidney Injury
- Keywords
- Hypotension, Kidney injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plasmalyte 3ml/kg/hr group | Active comparator | Drug: Plasmalyte 3ml/kg/hr group |
| Plasmalyte 6ml/kg/hr group | Active comparator | Drug: Plasmalyte 6ml/kg/hr group |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between 18-89 years of age
- undergoing pulmonary lobectomy with open or video assisted thoracotomy
Key exclusion criteria (12 listed)
- patient refusal
- pregnancy
- cardiac arrhythmia
- pacemaker dependency
- severe aortic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmalyte 3ml/kg/hr groupThis group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them | Drug | Plasmalyte 3ml/kg/hr group |
| Plasmalyte 6ml/kg/hr groupThis group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them | Drug | Plasmalyte 6ml/kg/hr group |
Primary outcome
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.
4 secondary outcomes
Length of Surgical Intensive Unit Stay/Hospital Stay
Time frame: Up to 7 days
Removal of Chest Tubes
Time frame: Post-op up to 48 hours
Development of Morbidity
Time frame: Up to 7 days
Death
Time frame: Assessed up to 30 days Post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamas Seres, M.D., PH.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasmalyte 3ml/kg/hr group and Plasmalyte 6ml/kg/hr group in people with Hypotension and Kidney Injury, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Renal Injury (time frame: Post-op up to 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.