Dextran-based Priming vs. Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

Heart Disease Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Dextran-based Priming (PrimECC), and Standard Crystalloid and Mannitol-based Priming Solution in Adult Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767154
• Other study ID #: 1003-15
• Status: Completed
• Phase: Phase 2
• First received: April 12, 2016
• Last updated: October 6, 2017
• Start date: May 2016
• Est. completion date: July 13, 2017

Study information

• Verified date: October 2017
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare two priming solutions for extracorporeal circulation, one based on Dextran 40, one based on crystalloid and mannitol. Primary endpoint is oncotic pressure during cardiopulmonary bypass. Secondary endpoints included fluid balance and organ functions.

Description:

This is a prospective, single center, double-blinded, randomized controlled clinical trial. Eighty patients are randomized 1:1 to either cardiopulmonary bypass with the dextran-based solution or standard priming with Ringer-Acetate and Mannitol.

Primary endpoint will be oncotic pressure during cardio pulmonary bypass. Secondary endpoints include perioperative fluid balance, coagulation, platelet function, postoperative bleeding volume, transfusion requirements, renal function, liver function, pulmonary function, inflammatory activation and markers for brain and heart injury.

Blood samples for oncotic pressure measurements will be collected from an arterial line before and during surgery. Organ function will be assessed before surgery and 2 hours cardio pulmonary bypass.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 13, 2017
• Est. primary completion date: July 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 50 - 75 years

• Elective cardiac surgery procedure with expected CBP time above 90 minutes

• Subject provides a legally effective informed consent.

Exclusion Criteria:

• Known previous cardiac surgery

• Coagulation disorder

• Malignancy

• Kidney failure

• Liver failure

• Ongoing septicaemia

• Ongoing antithrombotic treatment other than acetylsalicylic acid

• Systemic inflammatory disorders treated with corticosteroids

• Not able to understand Swedish

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Device:
• A colloid Dextran 40 solution for extracorporeal circulation
The oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved.
• Ringer-Acetate and Mannitol
Currently clinic standard for priming the CPB circuit.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	VGR

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in oncotic pressure in plasma	The oncotic pressure in plasma is measured using an Osmomat 050 and reported in kPa. Points of measurement is before ECC and at 60 minutes into ECC	After 1 hour of cardiopulmonary bypass
Secondary	Change in fluid balance	Patient fluid balance is registered from ECC-start until 24 hours post-ECC. Infusion of crystalloids and colloids and urine output is registered in ml.	Within 24 hours after cardiopulmonary bypass
Secondary	Amount of bleeding	Bleeding is registered from ECC-start until 24 hours post-ECC. Intraoperative bleeding and postoperative chest tube drainage for 24 hours are added and registered in ml.	Within 24 hours after cardiopulmonary bypass
Secondary	Amount of transfusions	Transfusions of red blood cells, platelets and plasma from ECC-start until 24 hours post-ECC are registered and reported in ml.	Within 24 hours after cardiopulmonary bypass
Secondary	Change in coagulation (1).	Blood samples will be analyzed with modified rotational thromboelastometry (ROTEM) and calibrated automated thrombography. Points of measurement will be before ECC and at 2 hours post-ECC. Results will be reported as normal, above normal or below normal.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in coagulation (2).	Blood samples will be analyzed calibrated automated thrombography. Points of measurement will be before ECC and at 2 hours post-ECC. Results will be reported as normal, above normal or below normal.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in platelet function	Platelet function will be measured with impedance aggregometry (Multiplate). Points of measurement will be before ECC and at 2 hours post-ECC. Results will be reported as normal or below normal.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in renal function (1)	Renal function is measured as µmol/L of Creatinine in serum. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in renal function (2)	Renal tubular damage is measured by analysis of U-NAG. Urine is collected before ECC and at 60 minutes into ECC. Results will be reported as U-NAG/U-Creatinine ratio (U/min).	After 1 hour of cardiopulmonary bypass
Secondary	Change in liver function (1)	The liver function is measured as µkat/L of ASAT in serum. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in liver function (2)	The liver function is measured as µkat/L of ALAT in serum. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in pulmonary function	The pulmonary function is measured by arterial blood gases assessing PaO2/FiO2 and reported in mmHg. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in ischemic heart injury marker.	The ischemic status of the heart is measures as ng/L of highly sensitive Troponin-T. Points of measurement will be before ECC and at 24 hours post-ECC.	Within 24 hours after cardiopulmonary bypass
Secondary	Change in brain injury marker (1)	Brain damage is measured as ng/L Tau in plasma. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in brain injury marker (2)	Brain damage is measured as ng/L of NFL in serum. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in brain injury marker (3)	Brain damage is measured as µg/L of S100B in serum. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in brain injury marker (4)	Brain damage is measured as µg/L of NSE in serum. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass
Secondary	Change in inflammatory activation	Inflammatory activation is measured as ng/L of IL-6 in plasma. Points of measurement will be before ECC and at 2 hours post-ECC.	Within 2 hours after cardiopulmonary bypass