Health TrialsbyHealthPanel

Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

ConditionsTranscatheter Aortic Valve ReplacementHemodynamic StabilityAnesthesia Induction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAir Force Military Medical University, China

About this trial

The purpose of this study is to evaluate whether the administration of 5 ml/kg of colloid solution prior to anesthesia induction, compared with 5 ml/kg of lactated Ringer's solution, can reduce hemodynamic fluctuations during the induction period (defined as the first 15 minutes after induction) in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Patients scheduled to undergo elective TAVR under general anesthesia;

Disqualifiers

Allergy to hydroxyethyl starch, its components, and/or sodium lactate Ringer's solution, or a history of colloidal allergy;

Severe cardiac dysfunction (ejection fraction[EF] < 35%);

Severe renal dysfunction (creatinine > 132 μg/L and/or requiring renal replacement therapy);

Morbid obesity (body mass index[BMI] > 37.5 kg/m² or > 32.5 kg/m² with metabolic diseases);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hydroxyethyl starch 130/0.4

    Drug

    5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.

  • Lactate Ringer's Solution

    Drug

    5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: ColloidExperimental treatment 1 intervention
Group B: CrystalloidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period.

The AUC below baseline MAP is calculated as: ∑ (((Si - Sbaseline)+(Si-1 - Sbaseline))/2 × ΔX) where Sbaseline is the baseline MAP, Si is the MAP at minute i (i = 0.5, 1, 1.5…15), and ΔX is the time interval between measurements.

Time frame
induction period, at an average of 15 minutes

Secondary outcomes

1

Incidence of post-induction hemodynamic instability, defined as arterial pressure (MAP)< 65 mmHg or a decrease of more than 20% from baseline within 15 minutes after induction.

Time frame
15 minutes after induction
2

Intraoperative use of vasoactive drugs.

Time frame
Intraoperative period, at an average of 2 hours
3

Sequential Organ Failure Assessment(SOFA )score on the first postoperative day

SOFA score grades organ dysfunction from 0 (normal) to 4 (most abnormal) for six organ systems . The total score is the sum of all six sub-scores, ranging from 0 to 24 . The higher score means the worse organ function.

Time frame
The first postoperative day, at 24 hours after surgery
4

Length of hospital stay.

Time frame
The duration of the patient's hospitalization after the initial surgery, at an average of 5 days.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Air Force Military Medical University, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: