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

NCT02767154 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-10-09

No results posted yet for this study

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

Interventions

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.

DEVICE

Ringer-Acetate and Mannitol

Currently clinic standard for priming the CPB circuit.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-07-12
Completion
2017-07-13

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02767154 on ClinicalTrials.gov