"The Effect of Reduced Fluid Load After Cardiac Surgery"

This study has been withdrawn prior to enrollment.
(Changes in staff resulted in logistic difficulties to perform the study)
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT01438502
First received: September 19, 2011
Last updated: November 23, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Fluid Overload
Organ Edema
Organ Function
Drug: HyperHAES® (hypertonic saline/HES)
Phase 0

Study Type: Observational
Official Title: "The Impact of Hypertonic Saline/ Colloids Infusion During Cardio-pulmonary-bypass in Patients Expected Long CPB-time"

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Reduction of organ edema and improved organ function [ Time Frame: 24-hours postoperatively ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 0
Groups/Cohorts Assigned Interventions
HyperHAES 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)).
Other Name: HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-stivelse (200/0.5)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01438502     History of Changes
Other Study ID Numbers: 2011/491
Study First Received: September 19, 2011
Last Updated: November 23, 2013
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Haukeland University Hospital:
cardiac surgery
cardio-pulmonary-bypass

Additional relevant MeSH terms:
Edema
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014