MedDataX Logo

Evaluation of Different Priming Solutions Effects on Microcirculation, Oxidative Stress and Morbidity in Cardiovascular Surgery Patients

NCT ID: NCT02501681

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pre-op Fluid Study

NCT05079269

Hypotension Drug-Induced Anesthesia
ACTIVE_NOT_RECRUITING NA

The Impact of Intra-operative Fluid Infusion Rate on Microcirculation

NCT05606536

Fluid Therapy Microcirculation Hemodilution
RECRUITING NA

Effects of Fluid Therapy on Microcirculatory Reactivity

NCT04982016

Microcirculation Fluid Therapy
UNKNOWN NA

Limiting IV Chloride to Reduce AKI After Cardiac Surgery

NCT02020538

Patients Undergoing Cardiothoracic Surgery
COMPLETED NA

Fluid Challenges and Microcirculation

NCT04559178

Surgery
TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

For integrative investigation of the effects of priming solution and postoperative fluid management on the complex interrelation between microcirculation and reactive oxygen species; sublingual microcirculation using microcirculation imaging system (IDF, Cytocam, NL) will be displayed and measure ekstra vascular lung water (EVLW) using PiCCO and plasma levels of oxidative stress markers will be measured. Sublingual tissue microcirculation will be evaluated in all patients at different time points as before induction (T0), after induction (T1), before cross clamping-hypothermic period (T2), after cross clamping (T3), before end of pump (normothermic period, heating) (T4), acceptance to intensive care unit (T5), third hour after surgery (T6) and twenty forth hour after surgery (T7).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microcirculation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

crystalloid

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

Group Type ACTIVE_COMPARATOR

priming solution during cardiovascular surgery

Intervention Type OTHER

colloid

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

Group Type ACTIVE_COMPARATOR

priming solution during cardiovascular surgery

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

priming solution during cardiovascular surgery

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* cardiovascular surgery needed

Exclusion Criteria

* no informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matty Koopmans

MSc

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Centre Leeuwarden

Leeuwarden, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Atadek 2014-723

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CPB Prime Fluid Strategies to Preserve Mcirocirculatory Perfusion
NCT05647057 COMPLETED NA
Fluid Infusion During Breast Surgery
NCT00431743 UNKNOWN PHASE4
Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients
NCT07329660 NOT_YET_RECRUITING NA
Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II
NCT05647200 UNKNOWN NA
Assessment of Fluid Responsiveness in Patients After Cardiac Surgery
NCT02571465 COMPLETED
Fluid Responsiveness in the Postoperative Patient: a Prospective Study
NCT02418663 UNKNOWN NA
Pre-Procedural Fasting in Cardiac Intervention
NCT02562638 UNKNOWN NA
Albumin Utilization in Adult Cardiac Surgical Patients: Retrospective
NCT06322537 ACTIVE_NOT_RECRUITING
Hemodynamic Response During Goal Directed Fluid Therapy in the OR
NCT02365688 TERMINATED NA
Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery
NCT02638623 COMPLETED NA
Efficacy of Prothrombin Complex Concentrate Reducing Perioperative Blood Loss in Cardiac Surgery
NCT04244981 RECRUITING PHASE4
Role of Inhaled Nitric Oxide in Vascular Mechanics and Right Ventricular Function
NCT06097026 RECRUITING NA
Prevalence of Preoperative Dehydration in Major Elective Urologic Surgery and Its Impact on Postoperative Outcome
NCT03788070 TERMINATED
Traditional Versus ScvO2 Guided Perioperative Fluid Therapy
NCT00468793 COMPLETED PHASE4
Remote Ischemic Preconditioning in Cardiac Surgery Trial
NCT01071265 COMPLETED NA
Ischemic Postconditioning in Cardiac Surgery
NCT01813968 COMPLETED NA
Pre-operative Exposure to SGLT2 Inhibitors and Post-operative Acute Renal Failure in Cardiac Surgery: a Retrospective Monocentric Cohort Study
NCT06453161 COMPLETED
Cerebral Energy State in Cardiac Surgery
NCT02846818 COMPLETED NA
Carotid Flow Time Measurement Guided Fluid Management During Spinal Anesthesia
NCT03734497 UNKNOWN NA
Perioperative Cardiac Arrest and Outcome
NCT05316779 COMPLETED
the PRECious Trial: PREdiction of Complications
NCT02102217 COMPLETED NA
The Effects of Intravenous Fluids on Perfusion Index and Pleth Variability Index
NCT03048162 COMPLETED NA
Perioperative Fluid Therapy Optimization in Spinal Surgery
NCT03644654 COMPLETED NA
Extended Perioperative Administration of Fibrinolysis Inhibitors After Cardiac Surgery
NCT06493227 RECRUITING NA
Ability of Changes in End Tidal Carbon Dioxide to Assess the Stroke Volume Effects of a Volume Expansion of 250ml of Crystalloid in the Operating Room
NCT03635307 COMPLETED