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Hydroxyethyl Starch Versus Crystalloid and Postoperative Major Adverse Kidney Complications Phase 4 1.292

Noch nicht rekrutierend
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Die klinische Studie NCT07410988 untersucht Behandlung im Zusammenhang mit Herzchirurgie. Diese interventionsstudie der Phase 4 hat den Status noch nicht rekrutierend. Der Start ist für 1. April 2026 geplant, bis 1.292 Teilnehmer aufgenommen werden. Durchgeführt von Nationaluniversität Seoul wird der Abschluss für 31. Mai 2029 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. März 2026 aktualisiert.
Kurzbeschreibung
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.
Offizieller Titel

Effect of 130/0.4 Hydroxyethyl Starch vs. Balanced Crystalloid for Intraoperative Fluid Therapy on Major Composite Renal Outcomes After Cardiac Surgery: a Multicenter, Randomized Controlled Trial

Erkrankungen
Herzchirurgie
Weitere Studien-IDs
  • SPROUT-5
NCT-Nummer
NCT07410988
Studienbeginn (tatsächlich)
2026-04-01
Zuletzt aktualisiert
2026-03-12
Studienende (vorauss.)
2029-05-31
Geplante Rekrutierung
1.292
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Noch nicht rekrutierend
Stichwörter
hydroxyethyl starch
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Dreifach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellHydroxyethyl starch
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
Volulyte® (6% HES 130/0.4 in balanced solution)
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.
Aktives VergleichspräparatBallanced crystalloid
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).
Kristalloide Lösungen
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).
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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).
For up to 7 days post-surgery
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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.
From intensive card unit admission after surgery to 6 hours post-admission
Vasopressor-free days
The number of days alive and free from intravenous vasopressor support (e.g., dopamine, phenylephrine, epinephrine, or norepinephrine)
From intensive care unit admission after surgery to postoperative day 14
Peak increase in serum creatinine
the maximum increase in serum creatinine from the preoperative baseline during the first 3 postoperative days
From entollment to postoperative day 3
Maximum stage of acute kidney injury
From the end of surgery to postoperative day 7
Teilnahme-Assistent
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
19 Years
Zugelassene Geschlechter
Alle
  • Patients aged 19 years or older scheduled for coronary artery bypass grafting (CABG), heart valve surgery, and/or thoracic aortic surgery

  1. Emergency surgery;
  2. Planned implantation of a durable left ventricular assist device;
  3. History of starch allergy or hypersensitivity;
  4. History of kidney transplantation;
  5. Preoperative end-stage renal disease (ESRD) or requirement for renal replacement therapy (RRT);
  6. Preoperative glomerular filtration rate < 30 mL/min/1.73 m2;
  7. Planned intraoperative and postoperative RRT;
  8. Preoperative use of mechanical circulatory support devices (e.g., intra-aortic balloon pump, extracorporeal membrane oxygenation, etc.);
  9. Significant clinical coagulopathy (e.g., active bleeding disorder or thrombocytopenia with a platelet count <100,000/µL);
  10. Active infective endocarditis.
Seoul National University Hospital logoNationaluniversität Seoul
Verantwortliche Partei
Karam Nam, MD, Hauptprüfer, Clinical Associate Professor, Seoul National University Hospital
Zentrale Studienkontakte
Kontakt: Karam Nam, M.D., Ph.D., +82 2 2072 0643, [email protected]
4 Studienstandorte in 1 Ländern
Chungnam National University Hospital, Daejeon, 35015, South Korea
Korea University Guro Hospital, Seoul, 03080, South Korea
Seoul National University Hospital, Seoul, 03080, South Korea
Karam Nam, Kontakt, +82 2 2072 0643, [email protected]
Severance Hospital, Seoul, 03080, South Korea