The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols

NCT01511120 | Completed Phase 2 DMC

• 1 other identifier: 2011/498
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

"The impact on fluid loading after cardiac surgery by use of two different priming solution" 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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• Reduction of organ edema and improved organ function

  As a target of 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, andf lung function will be measured by EVLWI(extravascular lungwater index).paO2/FiO2-ratio and time spent in respirator.Additionally a strict account for fluid balance will be kept.

  6-hours postoperatively

Study Arms (1)

Tetraspan

ACTIVE COMPARATOR

Drug: Tetraspan; Drug: acetated Ringer's solution

Interventions

Tetraspan DRUG

Also known as: Tetraspan® (HES 130/0,42 , 6%),, B. Braun Medical AS, Kjernåsveien 13 B, 3142 Vestskogen

Tetraspan

acetated Ringer's solution DRUG

Tetraspan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing CABG,
• EF(ejection fraction) more than 40%

You may not qualify if:

• Reduced EF (less than 40%) EVF less than 30%,
• Estimated GFR less than 60%,
• BMI less than 18 or more than 32

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Hjerteavdelingen, thoraxkirurgisk seksjon, Haukeland Universitetssykehus

Bergen, 5021, Norway

Location

Related Publications (1)

• 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.

  PMID: 29199540 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: January 18, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 12, 2015

Record last verified: 2013-08

Locations

NO (1)