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

NCT02767154 | Completed Phase 2 DMC

• 1 other identifier: 1003-15
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Disease

Keywords

extracorporeal circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change in fluid balance

  Within 24 hours after cardiopulmonary bypass

• Amount of bleeding

  Within 24 hours after cardiopulmonary bypass

• Amount of transfusions

  Within 24 hours after cardiopulmonary bypass

• Change in coagulation (1).

  Within 2 hours after cardiopulmonary bypass

• Change in coagulation (2).

  Within 2 hours after cardiopulmonary bypass

Study Arms (2)

PrimECC

ACTIVE COMPARATOR

1250 ml of a priming solution based on the colloid Dextran 40 to use for extracorporeal circulation.

Device: A colloid Dextran 40 solution for extracorporeal circulation

Ringer-Acetate/Mannitol

ACTIVE COMPARATOR

1250 ml of a priming solution based on the crystalloid Ringer-Acetate (1000ml) and Mannitol (250ml).

Device: Ringer-Acetate and Mannitol

Interventions

A colloid Dextran 40 solution for extracorporeal circulation DEVICE

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.

Also known as: PrimECC

PrimECC

Ringer-Acetate and Mannitol DEVICE

Currently clinic standard for priming the CPB circuit.

Also known as: Standard crystalloid prime

Ringer-Acetate/Mannitol

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 - 75 years
• Elective cardiac surgery procedure with expected CBP time above 90 minutes
• Subject provides a legally effective informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, VGR, 41345, Sweden

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Extracorporeal Circulation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor/Senior consultant

Study Record Dates

• First Submitted: April 12, 2016
• First Posted: May 10, 2016
• Study Start: May 1, 2016
• Primary Completion: July 12, 2017
• Study Completion: July 13, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)