Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

This trial aims to compare two intraoperative fluids, namely hydroxyethyl starch (HES) and balanced crystalloids in terms of major adverse kidney events after cardiac surgery. Indications for the study fluids administarion include preload augmentation and intravascular volume replacement during cardiac surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery

Disqualifiers

Emergency surgery;

Planned implantation of a durable left ventricular assist device;

History of starch allergy or hypersensitivity;

History of kidney transplantation;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Volulyte® (6% HES 130/0.4 in balanced solution)

    Drug

    Hydroxyethyl starch is used (up to 20 mL/kg) when acute volume resuscitation is required (e.g., preload augmentation, intravascular volume replacement) during cardiac surgery.

  • Crystalloid solutions

    Drug

    Balanced crystalloids are used instead of HES for the same indications as those in the HES group (when acute volume resuscitation is required \[e.g., preload augmentation, intravascular volume replacement\] during cardiac surgery).

Treatment groups

1,292 Participants
are divided into 2 treatment groups
Group A: Hydroxyethyl starchExperimental treatment 1 intervention
Group B: Ballanced crystalloidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of major adverse kidney events (MAKE)

The incidence of a composite outcome consinsting of all-cause mortality (patients who dies from any cause after surgery), stage 2 (an increase in serum creatinine to 2.0-2.9 times the baseline value) or stage 3 (an increase in serum creatinine to ≥3.0 times the baseline value or to an absolute level of ≥4.0 mg/dL) acute kidney injury, or new requirement for renal replacement therapy (de novo renal replacement therapy after surgery among patients who were renal replacement therapy-naive before surgery).

Time frame
For up to 7 days post-surgery

Secondary outcomes

1

Generalized average real variability

The sum of absolute differences between consecutive mean arterial pressure measurements, divided by the total monitoring duration from the first to the last measurement.

Time frame
From intensive card unit admission after surgery to 6 hours post-admission
2

Vasopressor-free days

The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, norepinephrine, or vasopressin)

Time frame
For up to 14 days post-surgery
3

Peak increase in serum creatinine

the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days

Time frame
From entollment to postoperative day 3
4

Maximum stage of acute kidney injury

Time frame
From the end of surgery to postoperative day 7

Other outcomes

1

Chest tube drainage during the first 12 hours after surgery (mL)

The cumulative volume of blood collected through the chest tube

Time frame
The first 12 hours following the completion of surgery
2

Incidence of reoperation for postoperative bleeding control

The proportion of patients requiring an unplanned return to the operating room for the purpose of controlling hemorrhage after initial operating theater exit.

Time frame
For up to 7 days post-surgery.
3

Plasma neutrophil gelatinase-associated lipocalin concentration

Time frame
Measured once at the end of surgery
4

Perioperative change in body weight

the difference between the first postoperative weight measurement and the most recent preoperative weight measurement (kg)

Time frame
From the most recent weight measurement before surgery until the first postoperative weight is recorded, typically spanning from the day before surgery to within several hours of the operation's completion.

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