The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols
NCT ID: NCT01511120
Last Updated: 2015-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2011-11-30
2013-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Fluid overloading with oedema formation is a regular finding following on-pump cardiac surgery and may contribute to postoperative organ dysfunction. Myocardial oedema has been reported to impair both systolic and diastolic function. An association between intraoperative fluid loading and postoperative adverse outcome has been demonstrated in cardiac patients.
The investigators have experience with the use of both colloides and combination fluids (hypertonic saline/colloides) in several experimental studies (pigs). In one animal study the investigators used colloides as an additive to the CPB-prime. The investigators observed reduced fluid leakage and less total tissue water in several organs.
The planned study includes patients scheduled for coronary artery bypass, and who have no co-morbidity. The patients will be randomized to receive either Tetraspan® (HES) or acetated Ringer's solution in the CPB-prime. Accurate accounts of fluid additions, blood loss and diuresis will be kept. Determination of cardiac output (C.O.), intrathoracic blood volume (ITBV), extravascular lung water (EVLW) and global end diastolic volume (GEDV) will be monitored by use of the transpulmonary thermodilution technique PiCCO®plus system.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Prime Solution on Fluid Balance After Open Heart Surgery
NCT00797589
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
NCT02782520
Heart-Lung Machine: Impact of the Priming Solution on Acid-Base Balance, Electrolytes and Outcome on Patients Undergoing Cardiac Surgery
NCT07267546
"The Effect of Reduced Fluid Load After Cardiac Surgery"
NCT01438502
Hypertonic Saline-hetastarch in Cardiac Surgery
NCT00469716
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tetraspan
Tetraspan
acetated Ringer's solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tetraspan
acetated Ringer's solution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* EF(ejection fraction) more than 40%
Exclusion Criteria
* Estimated GFR less than 60%,
* BMI less than 18 or more than 32
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Haukeland University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus
Bergen, , Norway
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Svendsen OS, Farstad M, Mongstad A, Haaverstad R, Husby P, Kvalheim VL. Is the use of hydroxyethyl starch as priming solution during cardiac surgery advisable? A randomized, single-center trial. Perfusion. 2018 Sep;33(6):483-489. doi: 10.1177/0267659117746235. Epub 2017 Dec 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011/498
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.