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HypotensionNCT04149314

The "Hypotension Prediction Index" in Patients Undergoing Lung Surgery

A study testing HPI based hemodynamic optimization algorithm in people with Hypotension and Hemodynamic Instability, run by University of Giessen at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HPI based hemodynamic optimization algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
1 siteGermany
Study dates
20 Nov 2019to 31 Oct 2023
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 undergoing lung surgery with one-lung-ventilation
  • General anesthesia
  • Age ≥ 18 years

Who cannot join

  • Participation in another (interventional) study
  • Pregnancy and nursing mothers
  • Surgery without controlled ventilation
  • ASA I or IV
  • Contraindication for invasive blood pressure monitoring
  • Coagulation disorder
  • Arterial Fibrillation

Trial locations and contacts

1 site in 1 country.

Germany1 site
  • Univeristy of Giessen

    Giessen, Hesse, 35392

Other trials in Germany

About this study

Official title: PGDT With the "Hypotension Prediction Index" to Reduce the Number and Duration of Intraoperative Hypotension and the Incidence of Renal Failure in Patients Undergoing Lung Surgery

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort.

The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.

Read the detailed description

Monitoring of blood pressure is a basic tool to assess the patients' hemodynamic status. Physiological blood pressure is usually close to 120/80 mmHg. Hypotension is not clearly defined as shown in previous studies 1, 20, 21. Some studies defined hypotension as a systolic blood pressure below 100 mmHg or a mean arterial pressure below 60 mmHg 1,2. Depending on the definition intraoperative hypotension (IOH) hypotension can occur in 38% of patients undergoing non-cardiac surgery. 53% of these patients die within one year. Monk et al. noted that the 1-year-mortality was raised by 3.6% for every minute the systolic blood pressure was below 80 mmHg. The risk of mortality was raised up to 1.4 times when the MAP was under 55 mmHg for more than 10 minutes 3. Additionally, in 2015 it was shown that even short duration of MAP under 55 mmHg is associated with a high risk for acute kidney injury and myocardial infarction 4. A recent definition of hypotension was published by of Vernooij et al. that defined IOH as a decrease of MAP < 65 mmHg for more than one minute in this study 22. Perioperative hypotension is a complication that can occur in the induction period and in the following phase. Recent unpublished data from the Sessler group presented at the 2018 ASA meeting in San Francisco showed that about 1/3 of hypotensive episodes are unrelated to surgery as those occur before the surgeon is in the OR 28. The reasons for hypotension can be found in vasodilatation (e. g. drug induced), volume deficit (based on blood loss), or negative inotropic effect of surgery and anesthetic drugs (reduced left ventricular function). Main factors causing intraoperative hypotension according to literature are age, preexisting diseases (especially ASA > 3), duration of surgery, acuteness of surgery (emergency), anti-hypertensive medication and anesthesia combining general and regional anesthesia 5,6. Complications related to hypotension can be detected in most organ systems. One important source of hypotension-associated complications are cardiovascular complications. Recently, a syndrome that was termed myocardial injury after non-cardiac surgery (MINS) was shown to be associated with hypotension and lead to increased postoperative mortality rate 23, 24. Acute kidney injury (AKI) affects up to 25% of patients in the intensive care unit 7. Liu et al. described that an episode of relative hypotension is often followed by AKI (a decrease in systolic blood pressure relative to pre-morbid value was a significant independent predictor of the development of AKI and of RIFLE classes I and F; odds ratio 1.084 for every -1 mmHg change in systolic blood pressure) 8. As stated, 'normotensive renal failure' is not common and a rare phenomenon in the absence of septic and other complications. This results are supported by other publications, like Lehmann et al. 9. Their results indicate that the risk of AKI was related to the severity of hypotension with an odds ratio (OR) of 1.03, 95% CI 1.02-1.04 (p < 0.0001) per 1 mmHg decrease in minimum MAP ≥ 80 mmHg. For each additional hour MAP was less than 70, 60, 50 mmHg, the risk of AKI increased by 2% (OR 1.02, 95% CI 1.00-1.03, p = 0.0034), 5% (OR 1.05, 95% CI 1.02-1.08, p = 0.0028), and 22% (OR 1.22, 95% CI 1.04-1.43, p = 0.0122).

Renal failure poses a relevant complication in the perioperative phase 5, 6. Over the last decade the cell cycle arrest biomarkers TIMP-2- and IGFBP7-quantification (Nephrocheck) has been successfully evaluated for the detection of AKI 7. The main advantage of both parameters is the opportunity of early detection of AKI and its point-of-care design, which makes them especially for the use on the intensive care unit valuable. Based on these facts, the predictive measurement of blood pressure is of great interest for the anesthesiologist to optimize patients' postoperative outcome.

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort.

The development of modern lung surgery started in the 19th century. Especially in Germany Rudolf Nissen (first pneumonectomy, 1931) and Ferdinand Sauerbruch were the first pioneers of lung surgery. With enhancement and refinement of thoracic anesthesiology (lung separation) and further specialization of surgery, thoracic surgery became a seperate discipline. During thoracic surgery lung separation and isolation with accomplished single-lung ventilation plays a key role in the development of thoracic surgery. Spectrum of indication contains thoracic surgery, procedure- and patient-dependent factors. Usually lung isolation is achieved with a double-lumen tube or a bronchial blocker. Major domain of thoracic surgery is nowadays oncological surgery of lung cancer. With modern imaging lung cancer is detected in early stage, so more operations can be performed. Additional in the last thirty years more and more minimal invasive procedures (VATS) were performed which result in gentle and successful treatment of thoracic surgical patients.

Beside oncological surgeries (which make almost 50% of all procedures in thoracic surgery) plays surgery of inflammable diseases and pulmonary emphysema a major role.

Approximately 182.821 thoracic surgical procedures are performed in Germany, 11.451 in Hessen. At the university clinic institution of Giessen more than 500 procedures are performed per year.

Hypotension Prediction Index The "Hypotension Prediction Index (HPI) "was established by the Edwards Lifescience Company (Irvine, USA) and is CE certified. The HPI displays the probability of an occurring hypotension before its onset and therefore can theoretically prevent episodes of hypotension by guiding earlier therapy. This might improve outcome in certain patient populations by preventing episodes of hypotension 29. A recent paper describes the methodology of this prediction tool 25.

Nephro Check NephroCheck is a point of care urine test that flags two biomarkers that indicate if a critically ill patient is at risk for acute kidney injury (AKI) 15. Currently, serum creatinine is the main test used to detect AKI, but it may take a day or more for serum creatinine levels to accumulate in the blood of a patient with a kidney injury consequently, it may not reflect real time kidney damage or loss of function 16. Results of the NephroCheck test are available within 20 minutes before clinical signs of kidney failure are apparent. The evidence suggests that the NephroCheck test has good sensitivity (89% at the 0.3 cutoff value) for detecting critically ill patients at risk for AKI 17, 18.

The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.

Being tested
HPI based hemodynamic optimization algorithm
Keywords
HPI, Thoracic Surgery, Single-Lung ventilation
Medical subject headings
Hypotension, Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HPI based hemodynamic optimization algorithmOther

    Interventional patients will be treated by a HPI-based hemodynamic optimization protocol including HPI, Stroke volume, cardiac index and mean arterial pressure.

Study groups in NCT04149314
Study groupRoleWhat they receive
InterventionalActive comparatorInterventional group (hemodynamic optimization based on HPI).
Receives: Other: HPI based hemodynamic optimization algorithm
ControlNo interventionControl group (blinded HPI monitoring, standard anesthesia care).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of intraoperative hypotension

    Frequency (n) and duration (t [min]) of intraoperative hypotension, defined as MAP below 65mmHg for one minute.

    Measured: up to 8 hours

Secondary outcomes (8)
  1. Renal failure

    Acute Kidney Injury Risk Score: (TIMP-2)x(IGFBD-7) The product of the measured concentrations out of a urin sample of the two biomarkers, TIMP-2 and IGFBP-7 (measured as ng/mL), divided by 1000 is the result measured as AKI (AcuteKidneyInjury) Risk score. Based upon results from clinical testing, intended use patients with AKIRISK® Scores < 0.3 are at lower risk of developing moderate to severe AKI within 12 hours of assessment than intended use patients with AKIRISK® Scores > 0.3.

    Measured: preoperative, immediately after operation and day 1 after operation

  2. Concentration of troponin

    MINS (Myocardiac injury after non-cardiac injury) defined as high troponin (µg/l) levels after admission to the ICU and day 1 after surgery

    Measured: preoperative, immediately after operation and day 1 after operation

  3. Hemodynamic status

    Volume loss and intake of iv fluids (crystalloid, colloidal, blood products and autologous blood) (in ml)

    Measured: up to 8 hours

  4. Procedual Data

    Duration of surgery and anesthesia

    Measured: until the end of anesthesia

  5. POMS (Postoperative Morbidity Survey Score)

    Postoperative Morbidity Survey Score. This score evaluates morbidity after elective surgery monitoring nine different categories.

    Measured: day 1, 3 and 5 after operation

  6. Circulation supportive mediaction

    Type and dosage of vasopressors and inotropic medication used during the procedure (in µg)

    Measured: from beginning until the end of surgery

  7. Hospital stay

    Hospital length of stay (in minutes) and Intensive care (ICU and IMCU) length of stay (in minutes)

    Measured: From admission to hospital until discharge of hospital up to 18 month

  8. Mortality after surgery

    Survival postoperative, 90 days after surgery, 180 days after surgery

    Measured: up to 180 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2019
  2. Study start20 Nov 2019
  3. Primary completion1 Jan 2023
  4. Study completion31 Oct 2023

Resources

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
Parallel groups
Model description
The study is designed as a single center randomized prospective blinded interventional trial comparing goal directed hemodynamic management using HPI compared to standard care.
Masking
Single blind
Who is masked
Investigator
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149314
Sponsor's protocol ID
HPI III
Status last verified
Nov 2023
First submitted
22 Jul 2019
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.

    PubMed 17667564
  • Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.

    PubMed 15616043
  • van Waes JA, van Klei WA, Wijeysundera DN, van Wolfswinkel L, Lindsay TF, Beattie WS. Association between Intraoperative Hypotension and Myocardial Injury after Vascular Surgery. Anesthesiology. 2016 Jan;124(1):35-44. doi: 10.1097/ALN.0000000000000922.

    PubMed 26540148
  • 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 23835589
  • Morris RW, Watterson LM, Westhorpe RN, Webb RK. Crisis management during anaesthesia: hypotension. Qual Saf Health Care. 2005 Jun;14(3):e11. doi: 10.1136/qshc.2002.004440.

    PubMed 15933284
  • Reich DL, Hossain S, Krol M, Baez B, Patel P, Bernstein A, Bodian CA. Predictors of hypotension after induction of general anesthesia. Anesth Analg. 2005 Sep;101(3):622-628. doi: 10.1213/01.ANE.0000175214.38450.91.

    PubMed 16115962
  • de Mendonca A, Vincent JL, Suter PM, Moreno R, Dearden NM, Antonelli M, Takala J, Sprung C, Cantraine F. Acute renal failure in the ICU: risk factors and outcome evaluated by the SOFA score. Intensive Care Med. 2000 Jul;26(7):915-21. doi: 10.1007/s001340051281.

    PubMed 10990106
  • Liu YL, Prowle J, Licari E, Uchino S, Bellomo R. Changes in blood pressure before the development of nosocomial acute kidney injury. Nephrol Dial Transplant. 2009 Feb;24(2):504-11. doi: 10.1093/ndt/gfn490. Epub 2008 Sep 3.

    PubMed 18768582
  • Lienhart A, Auroy Y, Pequignot F, Benhamou D, Warszawski J, Bovet M, Jougla E. Survey of anesthesia-related mortality in France. Anesthesiology. 2006 Dec;105(6):1087-97. doi: 10.1097/00000542-200612000-00008.

    PubMed 17122571
  • Owens P, O'Brien E. Hypotension in patients with coronary disease: can profound hypotensive events cause myocardial ischaemic events? Heart. 1999 Oct;82(4):477-81. doi: 10.1136/hrt.82.4.477.

    PubMed 10490564
  • Mitchinson MJ. The hypotensive stroke. Lancet. 1980 Feb 2;1(8162):244-6. doi: 10.1016/s0140-6736(80)90728-x.

    PubMed 6101689
  • Ovbiagele B, Diener HC, Yusuf S, Martin RH, Cotton D, Vinisko R, Donnan GA, Bath PM; PROFESS Investigators. Level of systolic blood pressure within the normal range and risk of recurrent stroke. JAMA. 2011 Nov 16;306(19):2137-44. doi: 10.1001/jama.2011.1650.

    PubMed 22089721
  • Merx H, Dreinhofer K, Schrader P, Sturmer T, Puhl W, Gunther KP, Brenner H. International variation in hip replacement rates. Ann Rheum Dis. 2003 Mar;62(3):222-6. doi: 10.1136/ard.62.3.222.

    PubMed 12594106
  • Kam Tao Li P, Burdmann EA, Mehta RL; World Kidney Day Steering Committee 2013. Acute kidney injury: Global health alert. J Nephropathol. 2013 Apr;2(2):90-7. doi: 10.12860/JNP.2013.15. Epub 2013 Apr 1.

    PubMed 24475433
  • Lewington AJ, Sayed A. Acute kidney injury: how do we define it? Ann Clin Biochem. 2010 Jan;47(Pt 1):4-7. doi: 10.1258/acb.2009.009249.

    PubMed 20040796

Questions about this trial

What is this clinical trial studying?

A study testing HPI based hemodynamic optimization algorithm in people with Hypotension and Hemodynamic Instability, run by University of Giessen at 1 site in Germany.

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 7 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 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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?

Incidence of intraoperative hypotension (time frame: up to 8 hours). 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 NCT04149314, which also lists 27 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 Dec 2023.

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