NCT02501681

Brief Summary

Single-centre prospective randomized study will be included the patients who undergo elective cardiovascular surgery. Preoperative fluid deficit will be calculated by the formula as starvation period X 4 X weight. Patients will be divided into two groups: Group A (n=20); crystalloid as priming solution used in patients, Group B (n=20); colloids as priming solution used in patients. In addition to priming solutions, extracorporeal pump will be filled with 150 mL of Mannitol, 60 mL of NaHCO3 and 10000 IU Insulin. Standard anesthesia protocol will be administered to all patients. Ringer's Lactate will be given at first 30 minute after induction. Ringer's Lactate as fluid maintenance will be administered at a rate of 100 mL/h except in extracorporeal circulation. Goal-directed fluid management will be performed by PVI (Pleth Variability Index). Cut off level of PVI will be accepted %15.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2015

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

July 13, 2015

Last Update Submit

August 18, 2015

Conditions

Microcirculation

Keywords

sublingual microcirculationcardiovascular surgery

Outcome Measures

Primary Outcomes (1)

  • change in microvascular flow index (MFI)

    hemodilution by the priming solutions in extracorporeal circulation affects the sublingual microcirculation

    1 day

Secondary Outcomes (1)

  • difference in MFI

    1 day

Study Arms (2)

crystalloid

ACTIVE COMPARATOR

Group A (n=20); crystalloid as priming solution used in patients,

Other: priming solution during cardiovascular surgery

colloid

ACTIVE COMPARATOR

Group B (n=20); colloids as priming solution used in patients

Other: priming solution during cardiovascular surgery

Interventions

priming solution during cardiovascular surgeryOTHER
colloidcrystalloid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cardiovascular surgery needed

You may not qualify if:

  • no informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Centre Leeuwarden

Leeuwarden, 8901 BR, Netherlands

Location

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 17, 2015

Study Start

February 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

NL(1)