"The Effect of Reduced Fluid Load After Cardiac Surgery"

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to verify that an infusion of hypertonic saline/colloids during cardio-pulmonary-bypass will reduce fluid overload and organ edema for cardiac patients with expected long-CPB-time.

Expected beneficial effects are improved organ function for heart and lungs.

Clinical Trial Description

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.

Our group has experience with the use of hypertonic saline/colloids in several experimental studies (pigs). In these animal studies we have used hypertonic saline/colloids both as an infusion during CPB or as an additive to CPB-prime. Both administration methods resulted in significant reduction in fluid loading due to better intravascular volume preservation.

One clinical study from our group observed reduced fluid load and an improved cardiac index when an infusion of hypertonic saline/colloids was used during cardiac surgery. Patients included in this study had a normal left ventricular function and no co-morbidity.

The planned study includes patients with combination procedures, both aorta coronary bypass and valve implantation, and expected long CPB-time.Time spent on CPB is a individual risk factor negatively associated with increased mortality and morbidity. The investigators believe high-risk patients will have even more benefit of reduced fluid loading. Their tolerance for hypovolemia is lower and the incidence for hemodynamic instability first hours postoperatively is greater.

The patients will be randomized to receive either a continuous infusion of hypertonic saline/colloids or acetated Ringer`s solution during CPB. 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.

Preoperative and postoperative echo cor will be performed. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01438502
Study type	Observational
Source	Haukeland University Hospital
Contact
Status	Withdrawn
Phase	Phase 0

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04095143` - Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Completed	`NCT05070819` - Atrial Natriuretic Peptide in Assessing Fluid Status	N/A
Withdrawn	`NCT04870073` - Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery	Phase 3
Recruiting	`NCT02989051` - Fluid Restriction Keeps Children Dry	Phase 2/Phase 3
Completed	`NCT00517127` - Crystalloids Versus Colloids During Surgery	Phase 4
Completed	`NCT00852514` - The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis	Phase 4
Not yet recruiting	`NCT05983549` - Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial	N/A
Completed	`NCT03929471` - Target Weight Correction and Vascular Stiffness in Hemodialysis Patients	N/A
Recruiting	`NCT06071026` - Hemodynamic Effects of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy.	N/A
Completed	`NCT02903316` - Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles	N/A
Terminated	`NCT02458157` - Forced Fluid Removal in High Risk Acute Kidney Injury	Phase 4
Completed	`NCT02325856` - Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients	N/A
Completed	`NCT01628731` - Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease	Phase 3
Not yet recruiting	`NCT05647200` - Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II	N/A
Completed	`NCT03768752` - Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients
Terminated	`NCT03553394` - Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients	N/A
Completed	`NCT06097923` - Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)	N/A
Recruiting	`NCT04215692` - Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients	N/A
Not yet recruiting	`NCT03322410` - Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.