An interventional study of Intraoperative hemodynamic management in Postoperative Acute Kidney Injury and Postoperative Complications, sponsored by Maria José Clara Colomina Soler. Completed at 26 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-01.
Sponsored by Maria José Clara Colomina Soler · Not applicable, Interventional, and Treatment
MAIN AIM OF THE STUDY To establish whether hemodynamic management guided by the hypotension prediction index (HPI) guided by the administration of intravenous fluids and vasoactive drugs in patients undergoing elective major abdominal surgery reduces the incidence of postoperative moderate-severe acute kidney injury (AKI) in the 30 days after surgery.
STUDY DESIGN A low intervention level clinical, blinded, controlled, randomized, multicenter, with daily follow-up of patients until hospital discharge and of postoperative complications and mortality 30 days after surgery will be performed.
This is a low-intervention clinical trial comparing standard treatments:
STUDY DISEASE Intraoperative hemodynamic monitoring and management in surgical patients undergoing major abdominal surgery.
STUDY POPULATION AND TOTAL NUMBER OF PATIENTS The sample of this study consists of patients of both genders, aged over 65 years and/or physical status ASA III or IV, undergoing elective major abdominal surgery (abdominal, urological, gynecological) under general/combined anesthesia (using laparoscopic or open approaches.
To detect a 5% absolute reduction (from 10% to 5%) in the primary outcome variable (postoperative AKI up to 30 days) with a sample size ratio of 1%, and an overall type I error rate of 5%, we need 870 patients (435 per arm). Assuming a 10% loss rate, the total amounts to 958 patients, 479 for each group.
DURATION OF THE STUDY The total planned duration of the overall study, which includes authorization, recruitment of subjects, and follow-up of subjects until completion of the analysis of the results obtained, is 19 months.
1,595 studies on the registry are indexed under Acute Kidney Injury; 370 are open to participants now.
This study's enrollment of 958 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →This is the only study on the registry with Maria José Clara Colomina Soler as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hemodynamic handling will be based hemodynamic prediction index (HPI)
Procedure: Intraoperative hemodynamic management
Patients in the control group will be treated according to standard practice.
Goal directed Hemodynamic therapy
Also known as: Fluid therapy
Acute kidney injury
The primary outcome is the occurrence of moderate or severe AKI (according to KDIGO Stage 2-3 criteria) within 30 days after surgery. AKI is classified according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria as follows: Stage 1: Increase in serum creatinine by 1.5 to 1.9 times baseline or increase in serum creatinine by 0.3 mg/dL, or reduction in urine output to \<0.5 mL/kg/hour for 6 to 12 hours. Stage 2: Increase in serum creatinine by 2.0 to 2.9 times baseline, or reduction in urine output to \<0.5 mL/kg/hour for \>12 hours. Stage 3: Increase in serum creatinine to 3.0 times baseline, or increase in serum creatinine to \>4.0 mg/dL or reduction in urine output to \<0.3 mL/kg/hour for \>24 hours, or anuria for \>12 hours, or initiation of renal replacement therapy, or, in patients \<18 years, decrease in estimated glomerular filtration rate (eGFR) to \<35 mL/min/1.73 m2.
Time frame: 7 days after surgery
Need for renal replacement therapy (RRT)
yes/no
Time frame: 30 days after surgery
renal replacement therapy (RRT) duration
days
Time frame: 30 days after surgery
Renal recovery on day 30
yes/no
Time frame: 30 days after surgery
Mortality
yes/no
Time frame: 30 days after surgery
Postoperative complications
According to:Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures
Time frame: 30 days after surgery
Postoperative length of stay
days
Time frame: 30 days after surgery
Number of days free from critical care
days
Time frame: 30 days after surgery
Plan to share: Yes — Upon specific request following the publication of the study
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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