Hypotension Prediction During Cardiac Surgery Postoperative Period

NCT05840432 | Unknown FDA Device

• 1 other identifier: PIC146-22_FJD
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about the performance of a new index for hypotension prediction during the immediate postoperative period of cardiac surgery patients in the intensive care unit. The main questions it aims to answer are:

1. 1.Is this new index, Hypotension Prediction Index, able to predict hypotension during the immediate postoperative period in cardiac surgery patients in the intensive care unit?
2. 2.How frequent hypotension is during the immediate postoperative period of cardiac surgery patients in the intensive care unit? Participants will not receive any treatment beyond the usual clinical practice during the study. All patients will have an invasive arterial line that is part of the usual clinical practice. This arterial line is connected to a pressure transducer for continuous measurement of arterial pressure. A transducer equipped with the necessary technology to calculate the hypotension prediction index will be used instead of the usual transducer. An echocardiogram will be performed in every patient in the study. This test is done frequently in patients after a cardiac surgery.

Conditions

Postoperative Hypotension

Keywords

hypotension prediction index; cardiac surgery; postoperative period

Outcome Measures

Primary Outcomes (1)

• HPI Performance on Hypotension Prediction

  Area Under the Receiver Operator Characteristic (ROC) curve for hypotension prediction, defining hypotension as mean arterial blood pressure below 65 mmHg for at least 1 minute.

  First 12 hours of the cardiac surgery postoperative period

Secondary Outcomes (11)

• Hypotension incidence

  First 12 hours of the cardiac surgery postoperative period

• Hypotension consequences: acute kidney injury

  Up to two months after surgery

• Hypotension consequences: myocardial injury

  First 7 days of ICU admission

• Hypotension consequences: prolonged mechanical ventilation

  Mechanical ventilation free days at 2 months

• Actions performed for hypotension management: vasopressors and inotropic drugs

  First 12 hours of the cardiac surgery postoperative period

Study Arms (1)

Cardiac Surgery Postoperative Patients

Cardiac Surgery Postoperative Patients who are admitted to the intensive care unit after the surgery, from the surgical room

Device: Postoperative hypotension prediction index

Interventions

Postoperative hypotension prediction index DEVICE

Performance of the hypotension prediction index (HPI) in predicting hypotension episodes in the first 12 h of cardiac surgery postoperative

Cardiac Surgery Postoperative Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients in the postoperative period of programmed cardiac surgery, who are admitted to the intensive care unit after the surgery. according to inverstigator and Hemosphere monitor disponibilty

You may qualify if:

• age ≥ 18 y.o.
• Programmed cardiac surgery
• Hemosphere platform availability
• Signed informed consent

You may not qualify if:

• Need for circulatory or respiratory mechanical assistance device support
• Urgent/emergent surgery

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead

Study Sites (1)

Intensive Care Unit. Hospital Universitario Fundación Jimenez Diaz

Madrid, 28040, Spain

RECRUITING

Related Publications (12)

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  PMID: 33334651 BACKGROUND

• Fischer GW, Levin MA. Vasoplegia during cardiac surgery: current concepts and management. Semin Thorac Cardiovasc Surg. 2010 Summer;22(2):140-4. doi: 10.1053/j.semtcvs.2010.09.007.

  PMID: 21092891 BACKGROUND

• Levin MA, Lin HM, Castillo JG, Adams DH, Reich DL, Fischer GW. Early on-cardiopulmonary bypass hypotension and other factors associated with vasoplegic syndrome. Circulation. 2009 Oct 27;120(17):1664-71. doi: 10.1161/CIRCULATIONAHA.108.814533. Epub 2009 Oct 12.

  PMID: 19822810 BACKGROUND

• Ouattara A, Boccara G, Kockler U, Lecomte P, Leprince P, Leger P, Riou B, Rama A, Coriat P. Remifentanil induces systemic arterial vasodilation in humans with a total artificial heart. Anesthesiology. 2004 Mar;100(3):602-7. doi: 10.1097/00000542-200403000-00021.

  PMID: 15108975 BACKGROUND

• Kotani Y, Yoshida T, Kumasawa J, Kamei J, Taguchi A, Kido K, Yamaguchi N, Kariya T, Nakasone M, Mikami N, Koga T, Nakayama I, Shibata M, Yoshida T, Nashiki H, Karatsu S, Nogi K, Tokuhira N, Izawa J. The impact of relative hypotension on acute kidney injury progression after cardiac surgery: a multicenter retrospective cohort study. Ann Intensive Care. 2021 Dec 20;11(1):178. doi: 10.1186/s13613-021-00969-4.

  PMID: 34928430 BACKGROUND

• de la Hoz MA, Rangasamy V, Bastos AB, Xu X, Novack V, Saugel B, Subramaniam B. Intraoperative Hypotension and Acute Kidney Injury, Stroke, and Mortality during and outside Cardiopulmonary Bypass: A Retrospective Observational Cohort Study. Anesthesiology. 2022 Jun 1;136(6):927-939. doi: 10.1097/ALN.0000000000004175.

  PMID: 35188970 BACKGROUND

• Weis F, Kilger E, Beiras-Fernandez A, Nassau K, Reuter D, Goetz A, Lamm P, Reindl L, Briegel J. Association between vasopressor dependence and early outcome in patients after cardiac surgery. Anaesthesia. 2006 Oct;61(10):938-42. doi: 10.1111/j.1365-2044.2006.04779.x.

  PMID: 16978306 BACKGROUND

• Parke RL, McGuinness SP, Gilder E, McCarthy LW. Intravenous fluid use after cardiac surgery: a multicentre, prospective, observational study. Crit Care Resusc. 2014 Sep;16(3):164-9.

  PMID: 25161017 BACKGROUND

• Meng L, Yu W, Wang T, Zhang L, Heerdt PM, Gelb AW. Blood Pressure Targets in Perioperative Care. Hypertension. 2018 Oct;72(4):806-817. doi: 10.1161/HYPERTENSIONAHA.118.11688. No abstract available.

  PMID: 30354725 BACKGROUND

• Hatib F, Jian Z, Buddi S, Lee C, Settels J, Sibert K, Rinehart J, Cannesson M. Machine-learning Algorithm to Predict Hypotension Based on High-fidelity Arterial Pressure Waveform Analysis. Anesthesiology. 2018 Oct;129(4):663-674. doi: 10.1097/ALN.0000000000002300.

  PMID: 29894315 BACKGROUND

• Davies SJ, Vistisen ST, Jian Z, Hatib F, Scheeren TWL. Ability of an Arterial Waveform Analysis-Derived Hypotension Prediction Index to Predict Future Hypotensive Events in Surgical Patients. Anesth Analg. 2020 Feb;130(2):352-359. doi: 10.1213/ANE.0000000000004121.

  PMID: 30896602 BACKGROUND

• Wijnberge 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.

  PMID: 32065827 BACKGROUND

Central Study Contacts

Arnoldo Santos, MD, PhD

CONTACT

0034915504800; asantos@fjd.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: May 3, 2023
• Study Start: February 16, 2023
• Primary Completion: January 31, 2024
• Study Completion: March 30, 2024
• Last Updated: November 14, 2023

Record last verified: 2023-02

Locations

ES (1)