"The Effect of Reduced Fluid Load After Cardiac Surgery"

Fluid Overload Clinical Trial

Official title:

"The Impact of Hypertonic Saline/ Colloids Infusion During Cardio-pulmonary-bypass in Patients Expected Long CPB-time"

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01438502
• Other study ID #: 2011/491
• Status: Withdrawn
• Phase: Phase 0
• First received: September 19, 2011
• Last updated: November 23, 2013

Study information

• Verified date: November 2013
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for combination surgery, both elective coronary bypass and valve surgery, with expected long CPB-time, and who after orally and written information agrees to participate in the study.

Exclusion Criteria:

• Age less than 18 years

• Serum-Sodium higher than 145 mmol/l

• Hematocrit less than 30 %

• Estimated GFR less than 60

• BMI more than 30 or BMI less than 18

Study Design

N/A

Related Conditions & MeSH terms

• Fluid Overload
• Organ Edema
• Organ Function

Intervention

Drug:
• HyperHAES® (hypertonic saline/HES)
After arrival to the operating theatre both study groups will receive an infusion of acetated Ringers solution 4 ml/kg/hour. Additionally both groups for 4 hours will receive 1 ml/kg/hour of a blinded solution. This solution will be either acetated Ringers solution or HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-starch (200/0.5)).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of organ edema and improved organ function	As a target for effect the investigators have chosen to study improvements for organ function. Indexed values for cardiac output (CI) measured by the PICCO system will be a parameter for heart function, and lung function will be measured by EVLWI (extravascular lung water index), paO2/FiO2 -ratio and time spent in respirator. Additionally a strict account for fluid balance will be kept.	24-hours postoperatively	Yes