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NCT Number: NCT02782520

Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery

This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.

Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.

Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).

Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.

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Key information

Conditions

Right Ventricular Impaired Function Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Reanimation Cardiovasculaire Et Thoracique

La Tronche, Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective valvular or coronary surgery
  • Under cardiopulmonary bypass
  • Patient requiring Swan Ganz catheter monitoring
  • Patient in sinus rhythm
  • Patient requiring post-operative volemic expansion
  • Echographic criteria of hypovolemia, without hypervolemia

Exclusion criteria

  • Pulmonary hypertension (SPAP > 60mmHg)
  • No pre-operative sinus rhythm
  • Emergency surgery
  • Age < 18 years
  • Chronic renal failure treated with dialysis
  • Severe hypernatremia

Treatment and study plan

Ringer Lactate (10ml/kg) fluid expansion

Drug

Hypertonic saline (3ml/kg) fluid expansion

Drug

Primary outcomes

  1. Right ventricular ejection fraction change measured by Swan Ganz catheter.

    Time frame: after 30 minutes perfusion ( fluid expansion)

Secondary outcomes

  1. Left ventricular contractility

    Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion

  2. Systolic volume change

    Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion

  3. Cardiac output evolution.

    Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion

  4. Tricuspid annular plane systolic excursion assessment

    Time frame: One hour before and after perfusion

  5. Continuous cardiac output

    Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion

  6. Blood volume efficiency

    Time frame: One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion

    Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure

  7. Plasmatic volume monitoring

    Time frame: One hour before and , 1, 6 and 18 hours after perfusion

    Plasmatic volume augmentation assessed by hemoglobin decrease

  8. Natremia level

    Time frame: at 1, 6 and 18 hours after perfusion

  9. Veinous oxygen saturation

    Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion

  10. Mean arterial pressure assessment.

    Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion

  11. Lactatemia level

    Time frame: at 1, 6 and 18 hours after perfusion

  12. Acid base balance assessment.

    Time frame: at 1, 6 and 18 hours after perfusion

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: SUCCESS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 25, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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