Postoperative Acute Kidney InjuryHYTNCT05569265
Hypotension Prediction Index-guided Hemodynamic Optimization Trial to Reduce Postoperative Acute Kidney Injury (HYT).
A study testing Intraoperative hemodynamic management in people with Postoperative Acute Kidney Injury and Postoperative Complications, run by Maria José Clara Colomina Soler at 26 sites in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Acute Kidney Injury, Postoperative Complications
- What is being tested?
- Intraoperative hemodynamic management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 958 participants
- Where
- 26 sitesSpain
- Study dates
- 8 Oct 2022to 25 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 65 years of age and/or physical condition ASA III or IV.
- Patients who have major elective abdominal surgery indicated: general surgery, urology, gynecology, by laparoscopic or open approaches.
- Patients who sign the informed consent, agreeing to participate in the study.
Who cannot join
- Stage 4 or 5 chronic kidney disease (eGFR < 15 ml/ min)
- Renal transplantation in the previous 12 months
- Glomerulonephritis, interstitial nephritis or vasculitis
- Anuria at inclusion
- Pre-existing AKI
- Renal replacement therapy (RRT) in the last 90 days
Show all 16Show fewer
- Indication for renal replacement at the time of inclusion
- Participation in another interventional trial investigating a drug/intervention affecting renal function
- Patients with atrial fibrillation
- Patients with known cardiac shunts.
- Patients whose surgical indication is urgent
- Pregnancy or lactation
- Patients expected to die within 30 days.
- Acute myocardial ischemia within the previous 30 days.
- Acute pulmonary edema within the previous 30 days
- Any contraindication to vasoactive or inotropic medication at low doses
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Spain26 sites
Hospital Universitario de Badajoz
Badajoz
Hospital Clínic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital Universitario de Sant Pau
Barcelona
Hospital Universitario Moises Brogi
Barcelona
Hospital Uniuversitario de Basurto
Bilbao
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Doctor Trueta
Girona
Hospital San Cecilio
Granada
Hospital Universitario Virgen de Las Nieves
Granada
Hospital Universitario Juan Ramón Jimenez
Huelva
Hospital Universitario de Igualada
Igualada
Hospital Universitario Jerez de la Frontera
Jerez de la Frontera
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria
Hospital Infanta Leonor
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Hospital Universitario Puerta de Hierro
Majadahonda
Althai Xarxa Universitaria
Manresa
Hospital Universitario de Donostia
San Sebastián
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Clínico Universitario de Santiago
Santiago de Compostela
Hospital Universitario Virgen de la Macaarena
Seville
Hospital Universitario Virgen del Rocío
Seville
Hospital General Universitario de Valencia
Valencia
Hospital Universitario Ríio Hortega
Valladolid
About this study
Official title: Open-label, Multicenter, Randomized, Controlled Trial of Hemodynamic Optimization Based on the Hypotension Prediction Index (HPI) Compared to Standard Practice in Adult Patients Undergoing Elective Major Abdominal Surgery.
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.
Read more
This is a low-intervention clinical trial comparing standard treatments:
- The drugs used in the investigation are licensed.
- The drugs are used according to the indications contemplated in the technical data sheet and there are published scientific data on their efficacy and safety.
- The complementary diagnostic or follow-up procedures entail a very limited additional risk or burden to the safety of the subjects, which is minimal compared to that of standard clinical practice.
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.
- Being tested
- Intraoperative hemodynamic management
- Keywords
- Perioperative care, Acute kidney injury, Hemodynamic prediction index, Major surgery
- Medical subject headings
- Postoperative Complications, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative hemodynamic managementProcedure or surgery
Also called Fluid therapy
Goal directed Hemodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic prediction index based goal directed hemodynamic therapy | Experimental | Hemodynamic handling will be based hemodynamic prediction index (HPI) Receives: Procedure: Intraoperative hemodynamic management |
| No HPI | No intervention | Patients in the control group will be treated according to standard practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after surgery
Secondary outcomes (7)
Need for renal replacement therapy (RRT)
yes/no
Measured: 30 days after surgery
renal replacement therapy (RRT) duration
days
Measured: 30 days after surgery
Renal recovery on day 30
yes/no
Measured: 30 days after surgery
Mortality
yes/no
Measured: 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
Measured: 30 days after surgery
Postoperative length of stay
days
Measured: 30 days after surgery
Number of days free from critical care
days
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start8 Oct 2022
- Primary completion15 Jan 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria José Clara Colomina Soler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria José Clara Colomina Soler, Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
- Investigators
- Javier Ripollés Melchor, MD, Study chair, Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569265
- Sponsor's protocol ID
- GFMH1
- Acronym
- HYT
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2022
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon specific request following the publication of the study
Publications
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
PubMed 32065827Ripolles-Melchor J, Carrasco-Sanchez L, Tome-Roca JL, Aldecoa C, Zorrilla-Vaca A, Lorente-Olazabal JV, Colomina MJ, Perez A, Jimenez-Lopez JI, Navarro-Perez R, Abad-Gurumeta A, Monge-Garcia MI; HYT Study Group. Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial. Trials. 2024 Apr 29;25(1):288. doi: 10.1186/s13063-024-08113-w.
PubMed 38685032
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multicenter, Randomized, Controlled Trial of Hemodynamic Optimization Based on the Hypotension Prediction Index (HPI) Compared to Standard Practice in Adult Patients Undergoing Elective Major Abdominal Surgery.
- ClinicalTrials.gov ID
- NCT05569265
- Acronym / sponsor ID
- HYT / GFMH1
- Keywords
- Perioperative care, Acute kidney injury, Hemodynamic prediction index, Major surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- Maria José Clara Colomina SolerUniversity, hospital or other
- Study start
- 8 Oct 2022 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The drugs used in the investigation are licensed.
- The drugs are used according to the indications contemplated in the technical data sheet and there are published scientific data on their efficacy and safety.
- The complementary diagnostic or follow-up procedures entail a very limited additional risk or burden to the safety of the subjects, which is minimal compared to that of standard clinical practice.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic prediction index based goal directed hemodynamic therapy | Experimental | Procedure: Intraoperative hemodynamic managementHemodynamic handling will be based hemodynamic prediction index (HPI) |
| No HPI | No intervention | –Patients in the control group will be treated according to standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 65 years of age and/or physical condition ASA III or IV.
- Patients who have major elective abdominal surgery indicated: general surgery, urology, gynecology, by laparoscopic or open approaches.
- Patients who sign the informed consent, agreeing to participate in the study.
Key exclusion criteria (16 listed)
- Stage 4 or 5 chronic kidney disease (eGFR < 15 ml/ min)
- Renal transplantation in the previous 12 months
- Glomerulonephritis, interstitial nephritis or vasculitis
- Anuria at inclusion
- Pre-existing AKI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative hemodynamic managementAlso: Fluid therapyGoal directed Hemodynamic therapy | Procedure or surgery | Hemodynamic prediction index based goal directed hemodynamic therapy |
Primary outcome
Acute kidney injury
Time frame: 7 days after surgery
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.
7 secondary outcomes
Need for renal replacement therapy (RRT)
Time frame: 30 days after surgery
renal replacement therapy (RRT) duration
Time frame: 30 days after surgery
Renal recovery on day 30
Time frame: 30 days after surgery
Mortality
Time frame: 30 days after surgery
Postoperative complications
Time frame: 30 days after surgery
Postoperative length of stay
Time frame: 30 days after surgery
Number of days free from critical care
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
- Background: PubMed 32065827Wijnberge M, Geerts BF, Hol L, Lemmers N, Mulder MP, Berge P, Schenk J, Terwindt LE, Hollmann MW, Vlaar AP, Veelo DP. Effect of a Machine Learning-Derived Early Warning System for Intraoperative Hypotension vs Standard Care on Depth and Duration of Intraoperative Hypotension During Elective Noncardiac Surgery: The HYPE Randomized Clinical Trial. JAMA. 2020 Mar 17;323(11):1052-1060. doi: 10.1001/jama.2020.0592.
- Derived from this study: PubMed 38685032Ripolles-Melchor J, Carrasco-Sanchez L, Tome-Roca JL, Aldecoa C, Zorrilla-Vaca A, Lorente-Olazabal JV, Colomina MJ, Perez A, Jimenez-Lopez JI, Navarro-Perez R, Abad-Gurumeta A, Monge-Garcia MI; HYT Study Group. Hypotension prediction index guided goal-directed therapy to reduce postoperative acute kidney injury during major abdominal surgery: study protocol for a multicenter randomized controlled clinical trial. Trials. 2024 Apr 29;25(1):288. doi: 10.1186/s13063-024-08113-w.
- Individual participant dataSharing planned: Yes. Upon specific request following the publication of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Ripollés Melchor, MD study chair
Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative hemodynamic management in people with Postoperative Acute Kidney Injury and Postoperative Complications, run by Maria José Clara Colomina Soler at 26 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute kidney injury (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05569265, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.