The Value of Peripheral Arterial Resistive Index in Evaluation of Tissue Perfusion in Patients With Septic Shock

NCT05902273 | Completed

• 1 other identifier: Bezmialem V U
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In patients with septic shock, routine arterial blood pressure and central venous pressure are monitored in ICU. Conventional methods such as blood pressure and central venous pressure in septic patients cannot provide sufficient information in the follow-up due to the body's compensation mechanisms. The systemic vascular resistance index, which can be measured invasively or non-invasively with advanced hemodynamic monitoring methods, is a parameter that plays an important role in the management of septic patients. Resistive index (Pourcelot Index) is an ultrasonic measurement method used to evaluate tissue perfusion and microcirculation. Since peripheral tissue perfusion is impaired in septic patients, the investigators think resistive index may be useful for management of sepsis. There are studies in the literature on the use of resistive index in the follow-up of patients. The study will be about whether there is a correlation between the systemic vascular resistance index measured by cardiac output measurement, which is one of the advanced monitoring methods routinely used in the group requiring mechanical ventilation support in patients with septic shock, and the peripheral arterial resistive index, which is routinely used to evaluate tissue perfusion and microcirculation.

Conditions

Shock, Septic

Keywords

Septic shock; SBRI; SVRI; systemic vascular resistance index; resistive index; Pourcelot index

Outcome Measures

Primary Outcomes (1)

• correlation of snuffbox radial artery resistive index and systemic vascular resistance index

  correlation of snuffbox radial artery resistive index and systemic vascular resistance index

  1 hour. As soon as patient meets all of the inclusion criteria

Secondary Outcomes (5)

• correlation of snuffbox radial artery resistive index and pleth variability index

  1 hour. As soon as patient meets all of the inclusion criteria

• correlation of snuffbox radial artery resistive index and delta stroke volume index

  1 hour. As soon as patient meets all of the inclusion criteria

• correlation of snuffbox radial artery resistive index and diastolic shock index

  1 hour. As soon as patient meets all of the inclusion criteria

• correlation of snuffbox radial artery resistive index and central vena cava oxygen saturation and partial carbon dioxide pressure gap

  1 hour. As soon as patient meets all of the inclusion criteria

• correlation of snuffbox radial artery resistive index and cardiac power index

  1 hour. As soon as patient meets all of the inclusion criteria

Study Arms (1)

septic shock patients

mechanically ventilated septic shock patients

Diagnostic Test: hemodynamic monitoring; Diagnostic Test: resistive index; Diagnostic Test: Pleth variability index

Interventions

hemodynamic monitoring DIAGNOSTIC_TEST

Baxter Starling Monitor for measuring cardiac output and systemic vascular resistance (SVRI) which is using bioreactance technology. We need to place four electrodes on chest wall (upper left, upper right, down left, down right) and input monitor demographic parameters. Also enter mean arterial pressure (MAP) for calculating SVRI so we input MAP every minute.Patient bed set as 45 degree head elevated and legs 0 degree. Just after start measuring, monitor needs to synchronize itself for patient. After synchronisation we start fluid challenge with passive leg raising option. This test has two stages. First stage calculating baseline parameters which takes 3 minutes and second stage is measuring difference with fluid challenge which also takes 3 minutes. At the end of first stage monitor shows to perform passive leg raise and we perform trendelenburg maneuver till head comes to 0 degree. After second stage measurement has finished.

Also known as: Non Invasive Cardiac Output Monitor (NICOM)

septic shock patients

resistive index DIAGNOSTIC_TEST

We use ultrasonography at the same time with cardiac output monitor in both stages. First we determine the location of radial artery at wrist snuffbox at 1.5 centimeters depth with linear probe and confirm pulsatile flow with color mode. In Starling's baseline stage we measure and calculate resistive index with doppler P-mode in triplex setting 3 times. When received 3 same result successively we noted as SBRI-1. Second measurement is initiated at last 30 seconds of passive leg raising as described before and we noted our measurement as SBRI-2

Also known as: SBRI, Snuffbox resistive index, Pourcelot index, doppler ultrasonography

septic shock patients

Pleth variability index DIAGNOSTIC_TEST

During all stages Masimo Rad-87 rainbow probe is placed patients index or middle finger and we note PVI-1 and PVI-2 at the same time with SBRI-1 and SBRI-2

Also known as: PVI, Rad-87

septic shock patients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who admited to intensive care unit of Bezmialem Vakıf Univesity Hospital

You may qualify if:

• \>18 years old
• admitted to intensive care for septic shock
• mechanical ventilated
• non spontaneous breathing
• applied invasive artery cannulation (radial, femoral, brachial)
• applied central venous catheter (jugular, subclavian)
• SOFA score\>2
• Receiving vasopressor/inotrope support to achieve MAP ≥65 mmHg
• Blood lactate \>2mmol/L

You may not qualify if:

• \<18 years old
• Hypothermia (\<35C)
• Atrial fibrilation/flutter
• Pace-maker
• Severe aort valve insufficiency
• History of aortic and the great arteries adjacent to the aortic arch surgery
• Bilateral radial artery puncture in last 12 hours
• Peripheral artery disease
• Extremity amputation (leg or arm)
• Wound on forearm
• Continous Renal Replacement Therapy
• Spontaneous breath effort

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (12)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.

  PMID: 11445675 BACKGROUND

• Cohen J, Vincent JL, Adhikari NK, Machado FR, Angus DC, Calandra T, Jaton K, Giulieri S, Delaloye J, Opal S, Tracey K, van der Poll T, Pelfrene E. Sepsis: a roadmap for future research. Lancet Infect Dis. 2015 May;15(5):581-614. doi: 10.1016/S1473-3099(15)70112-X. Epub 2015 Apr 19.

  PMID: 25932591 BACKGROUND

• Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

  PMID: 31954465 BACKGROUND

• Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.

  PMID: 16424713 BACKGROUND

• Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marshall JC, Bion J, Schorr C, Artigas A, Ramsay G, Beale R, Parker MM, Gerlach H, Reinhart K, Silva E, Harvey M, Regan S, Angus DC. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Intensive Care Med. 2010 Feb;36(2):222-31. doi: 10.1007/s00134-009-1738-3. Epub 2010 Jan 13.

  PMID: 20069275 BACKGROUND

• Levy MM, Artigas A, Phillips GS, Rhodes A, Beale R, Osborn T, Vincent JL, Townsend S, Lemeshow S, Dellinger RP. Outcomes of the Surviving Sepsis Campaign in intensive care units in the USA and Europe: a prospective cohort study. Lancet Infect Dis. 2012 Dec;12(12):919-24. doi: 10.1016/S1473-3099(12)70239-6. Epub 2012 Oct 26.

  PMID: 23103175 BACKGROUND

• Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.

  PMID: 24638143 BACKGROUND

• Reuter DA, Chappell D, Perel A. The dark sides of fluid administration in the critically ill patient. Intensive Care Med. 2018 Jul;44(7):1138-1140. doi: 10.1007/s00134-017-4989-4. Epub 2017 Nov 11. No abstract available.

  PMID: 29128963 BACKGROUND

• Kox M, Pickkers P. "Less is more" in critically ill patients: not too intensive. JAMA Intern Med. 2013 Jul 22;173(14):1369-72. doi: 10.1001/jamainternmed.2013.6702.

  PMID: 23752755 BACKGROUND

• Groeneveld AB, Nauta JJ, Thijs LG. Peripheral vascular resistance in septic shock: its relation to outcome. Intensive Care Med. 1988;14(2):141-7. doi: 10.1007/BF00257468.

  PMID: 3361019 BACKGROUND

• Ban K, Kochi K, Imai K, Okada K, Orihashi K, Sueda T. Novel Doppler technique to assess systemic vascular resistance: the snuffbox technique. Circ J. 2005 Jun;69(6):688-94. doi: 10.1253/circj.69.688.

  PMID: 15914947 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Hemodynamic Monitoring; Ultrasonography, Doppler

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic; Ultrasonography; Diagnostic Imaging

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 13, 2023
• Study Start: April 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

TU (1)