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

Grenoble Alpes University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Right Ventricular Impaired Function; Hypovolemia

Treatments: Drug: Ringer Lactate (10ml/kg) fluid expansion; Drug: Hypertonic saline (3ml/kg) fluid expansion

Study type: Interventional

Funder types: Other

Identifiers

NCT02782520

38RC15.214

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Ringer Lactate

Active Comparator group

Description:

Ringer Lactate group

Treatment:

Drug: Ringer Lactate (10ml/kg) fluid expansion

Hypertonic saline

Experimental group

Description:

Hypertonic saline group

Treatment:

Drug: Hypertonic saline (3ml/kg) fluid expansion