Hemodynamic StabilityPhase 2NCT02654782
Lactated Ringer's Versus 5% Human Albumin: Cardiac Surgical Patients
A Phase 2 study testing Lactated Ringer's and 5% Human Albumin in people with Hemodynamic Stability, run by William C. Oliver at 1 site in United States.
Trial summary
The purpose of this study is to show which of two different types of fluid is best for cardiac surgical patients. During and after the subject's heart surgery, the subject will be given either Lactated Ringer's or 5% human albumin to replace lost blood and body fluids and to regulate blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hemodynamic Stability
- What is being tested?
- Lactated Ringer's and 5% Human Albumin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 9 Oct 2017
- Phase
- Phase 2
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-pregnant female patients
- Patients undergoing elective cardiac surgery
- Aspirin, heparin, or warfarin preoperatively accepted
Who cannot join
- Previous sternotomy
- Emergency surgery
- Combined procedures (vascular or thoracic operations)
- Congenital heart repair
- Hypothermic cardiopulmonary bypass (CPB) < 28 degrees C
- Serum creatinine greater than or equal to 1.5 mg/dL
Show all 27Show fewer
- Dialysis dependent renal failure
- Neurologic injury or event within 30 days (including transient ischemic attack)
- Cerebrovascular accident with significant residual neurologic deficit
- Severe chronic obstructive pulmonary disease with Forced Expiratory Volume in 1 Second (FEV1) < 45% of predicted value
- Home oxygen use
- Previous difficult intubation
- Acute normovolemic blood conservation techniques
- Liver disease with serum aspartate aminotransferase (AST) > 31 U/L
- Circulatory arrest
- Thrombolysis
- Pre-existing clotting disorder
- Platelet receptor glycoprotein IIb/IIIa (GP IIb/IIIa) antagonist medication received within 48 hours
- Steroids
- Ejection Fraction < 40%
- Intra-aortic balloon pumps
- Ongoing congestive heart failure
- Ventricular assist devices
- Total hearts
- Pregnant women
- Adults lacking capacity to consent
- Any patients initially enrolled in the study that end up with an intra-aortic balloon pump, left ventricular assist device, or on extracorporeal membrane oxygenation will be eliminated from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients
The purpose of this study is to show which of two different types of fluid is best for cardiac surgical patients. During and after the subject's heart surgery, the subject will be given either Lactated Ringer's or 5% human albumin to replace lost blood and body fluids and to regulate blood pressure.
Albumin (human) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Albumin (human) 5% are provided by FDA approved blood establishments only.
Read more
Lactated Ringer's is a sterile, nonpyrogenic solution containing isotonic concentrations of electrolytes in water for injection. It is FDA approved for administration by intravenous infusion for parental replacement of extracellular losses of fluid and electrolytes.
The hypothesis of this study is that the individual total fluid volume and alveolar-arterial gradient will be less with 5% human albumin compared to Lactated Ringer's in the perioperative cardiac surgical patient.
Read the detailed description
Following Institutional Review Board (IRB) approval and written informed patient consent, 40 elective, cardiac surgical patients will be randomized to two different fluid therapy regimens, 5% human albumin only or Lactated Ringer's only, beginning in the intraoperative period and up to 6 hours in the intensive care unit. Providers and patients will be blinded to the fluid administered in the operating room and intensive care unit. The primary outcome measure will be the total volume of 5% human albumin or Lactated Ringer's given during the study period to maintain specified hemodynamic guidelines. Hemodynamic instability will be defined according to each patient's stipulated baseline parameters. Fluid will be administered at the request of providers in the operating room and intensive care unit in compliance with a perioperative fluid algorithm.
- Conditions
- Hemodynamic Stability
- Being tested
- Lactated Ringer's, 5% Human Albumin
- Keywords
- Lactated Ringer's, Human Albumin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactated Ringer'sDrug
Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.
5% Human AlbuminDrug
Colloid given for hemodynamic resuscitation based off of individual patient needs.
| Study group | Role | What they receive |
|---|---|---|
| Lactated Ringer's | Active comparator | Subjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. Receives: Drug: Lactated Ringer's |
| 5% Human Albumin | Active comparator | Subjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. Receives: Drug: 5% Human Albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Fluid Administered Indexed to Weight
Adequate fluid volume plays a major part in maintaining the necessary hemodynamics to prevent organ damage during cardiac surgery. This will be measured by the total volume of fluid administered to the subject from the start of surgery up to 6 hours in the intensive care unit.
Measured: Start of surgery up to 6 hours into the intensive care unit (ICU)
Secondary outcomes (1)
Alveolar-arterial Gradient
Alveolar-arterial gradient will be calculated from arterial blood gases on each patient. This value will be used to compare shunt in each arm.
Measured: Calculated throughout the study up to 6 hours in the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2016 (estimated)
- Study startJan 2016
- Primary completion9 Oct 2017
- Study completion9 Oct 2017
Why it stopped: Student performing study left Mayo Clinic, no funds to continue study.
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 Hemodynamic StabilityStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- William C. Oliver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, William C. Oliver, Mayo Clinic
- Investigators
- William Oliver, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02654782
- Sponsor's protocol ID
- 15-000858
- Status last verified
- Mar 2019
- First submitted
- 8 Jan 2016
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactated Ringer's Versus 5% Human Albumin: A Double-Blinded, Randomized, Prospective Study in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT02654782
- Acronym / sponsor ID
- 15-000858
- Conditions
- Hemodynamic Stability
- Keywords
- Lactated Ringer's, Human Albumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Student performing study left Mayo Clinic, no funds to continue study.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- William C. OliverUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 9 Oct 2017 (actual)
- Study completion
- 9 Oct 2017 (actual)
- First posted
- 13 Jan 2016 (estimated)
- Results
- Posted 16 Apr 2019
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 show which of two different types of fluid is best for cardiac surgical patients. During and after the subject's heart surgery, the subject will be given either Lactated Ringer's or 5% human albumin to replace lost blood and body fluids and to regulate blood pressure.
Albumin (human) 5% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of Albumin (human) 5% are provided by FDA approved blood establishments only.
Lactated Ringer's is a sterile, nonpyrogenic solution containing isotonic concentrations of electrolytes in water for injection. It is FDA approved for administration by intravenous infusion for parental replacement of extracellular losses of fluid and electrolytes.
The hypothesis of this study is that the individual total fluid volume and alveolar-arterial gradient will be less with 5% human albumin compared to Lactated Ringer's in the perioperative cardiac surgical patient.
Detailed description
Following Institutional Review Board (IRB) approval and written informed patient consent, 40 elective, cardiac surgical patients will be randomized to two different fluid therapy regimens, 5% human albumin only or Lactated Ringer's only, beginning in the intraoperative period and up to 6 hours in the intensive care unit. Providers and patients will be blinded to the fluid administered in the operating room and intensive care unit. The primary outcome measure will be the total volume of 5% human albumin or Lactated Ringer's given during the study period to maintain specified hemodynamic guidelines. Hemodynamic instability will be defined according to each patient's stipulated baseline parameters. Fluid will be administered at the request of providers in the operating room and intensive care unit in compliance with a perioperative fluid algorithm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactated Ringer's | Active comparator | Drug: Lactated Ringer'sSubjects randomized to Lactated Ringer's for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. |
| 5% Human Albumin | Active comparator | Drug: 5% Human AlbuminSubjects randomized to 5% human albumin for hemodynamic resuscitation. Volume will be decided based off of individual patient needs. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-pregnant female patients
- Patients undergoing elective cardiac surgery
- Aspirin, heparin, or warfarin preoperatively accepted
Key exclusion criteria (27 listed)
- Previous sternotomy
- Emergency surgery
- Combined procedures (vascular or thoracic operations)
- Congenital heart repair
- Hypothermic cardiopulmonary bypass (CPB) < 28 degrees C
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 |
|---|---|---|
| Lactated Ringer'sCrystalloid fluid given for hemodynamic resuscitation based off of individual patient needs. | Drug | Lactated Ringer's |
| 5% Human AlbuminColloid given for hemodynamic resuscitation based off of individual patient needs. | Drug | 5% Human Albumin |
Primary outcome
Total Fluid Administered Indexed to Weight
Time frame: Start of surgery up to 6 hours into the intensive care unit (ICU)
Adequate fluid volume plays a major part in maintaining the necessary hemodynamics to prevent organ damage during cardiac surgery. This will be measured by the total volume of fluid administered to the subject from the start of surgery up to 6 hours in the intensive care unit.
1 secondary outcome
Alveolar-arterial Gradient
Time frame: Calculated throughout the study up to 6 hours in the ICU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
William Oliver, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactated Ringer's and 5% Human Albumin in people with Hemodynamic Stability, run by William C. Oliver 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 3 inclusion and 27 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: stopped early, as of the sponsor's last update on 16 Apr 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 16 Apr 2019). 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?
Total Fluid Administered Indexed to Weight (time frame: Start of surgery up to 6 hours into the intensive care unit (ICU)). 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 16 Apr 2019.