Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

NCT03768752 | Completed

• 1 other identifier: DD-Sepsis
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is one of the most challenging conditions with an exceptionally high mortality rate. Diastolic Dysfunction is common in septic patients and has been found to be associated with mortality. However, the reasons for this remain unclear. Therefore, the goal of this study is to investigate diastolic dysfunction in septic patients on the intensive care unit. Special attention is paid to the presence of lung edema and general edema as a potential link between diastolic dysfunction and elevated mortality in septic patients. During the septic phase daily ultrasound examinations of heart and lung will be performed as to monitor diastolic function and lung edema.

Conditions

Sepsis; Diastolic Dysfunction; Lung Edema; Fluid Overload

Keywords

intensive care unit; echocardiography

Outcome Measures

Primary Outcomes (2)

• Diastolic Dysfunction

  Diastolic Dysfunction specified by echocardiographic doppler derived mitral inflow pattern and tissue doppler derived diastolic mitral annular velocities (E/E').

  While in septic condition, up to 10 days maximum.

• Pulmonary Edema

  Pulmonary edema specified by B line ultrasound score (Lung ultrasound protocol for the assessment of pulmonary fluid status according to Enghardt et al. 2015).

  While in septic condition, up to 10 days maximum.

Study Arms (2)

Diastolic Dysfunction

Patients with pre-existing or new diastolic dysfunction.

Normal Diastolic Function

Patients with normal diastolic function.

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

Patients on the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with sepsis.

You may qualify if:

• Patients on the intensive care unit diagnosed with SIRS (systemic inflammatory response syndrome) or Sepsis.

You may not qualify if:

• Patients with hemodynamically relevant cardiac defects.
• Patients with mitral valve replacement.
• Patients with pericardial effusion.
• Patients with atrial fibrillation.
• Patients with pacemaker therapy.
• Patients with BMI \> 35 kg/m2.
• Patients with poor examination conditions for ultrasound.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Universitätskrankenhaus Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (7)

• Fleischmann C, Scherag A, Adhikari NK, Hartog CS, Tsaganos T, Schlattmann P, Angus DC, Reinhart K; International Forum of Acute Care Trialists. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Current Estimates and Limitations. Am J Respir Crit Care Med. 2016 Feb 1;193(3):259-72. doi: 10.1164/rccm.201504-0781OC.

  PMID: 26414292 BACKGROUND

• Martin GS, Mannino DM, Eaton S, Moss M. The epidemiology of sepsis in the United States from 1979 through 2000. N Engl J Med. 2003 Apr 17;348(16):1546-54. doi: 10.1056/NEJMoa022139.

  PMID: 12700374 BACKGROUND

• Sanfilippo F, Corredor C, Fletcher N, Landesberg G, Benedetto U, Foex P, Cecconi M. Diastolic dysfunction and mortality in septic patients: a systematic review and meta-analysis. Intensive Care Med. 2015 Jun;41(6):1004-13. doi: 10.1007/s00134-015-3748-7. Epub 2015 Mar 24.

  PMID: 25800584 BACKGROUND

• Enghard P, Rademacher S, Nee J, Hasper D, Engert U, Jorres A, Kruse JM. Simplified lung ultrasound protocol shows excellent prediction of extravascular lung water in ventilated intensive care patients. Crit Care. 2015 Feb 6;19(1):36. doi: 10.1186/s13054-015-0756-5.

  PMID: 25656060 BACKGROUND

• Suehiro K, Morikage N, Murakami M, Yamashita O, Samura M, Hamano K. Significance of ultrasound examination of skin and subcutaneous tissue in secondary lower extremity lymphedema. Ann Vasc Dis. 2013;6(2):180-8. doi: 10.3400/avd.oa.12.00102. Epub 2013 May 10.

  PMID: 23825499 BACKGROUND

• Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.

  PMID: 8844239 BACKGROUND

• Kahl U, Schirren L, Yu Y, Lezius S, Fischer M, Menke M, Sinning C, Nierhaus A, Vens M, Zollner C, Kluge S, Goepfert MS, Roeher K. Left Ventricular Diastolic Dysfunction Is Not Associated With Pulmonary Edema in Septic Patients. A Prospective Observational Cohort Study. Front Cardiovasc Med. 2022 Jul 1;9:900850. doi: 10.3389/fcvm.2022.900850. eCollection 2022.

  PMID: 35845063 DERIVED

MeSH Terms

Conditions

Sepsis; Pulmonary Edema; Edema

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms

Study Officials

• Ursula Kahl, MD

  Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: November 30, 2018
• First Posted: December 7, 2018
• Study Start: October 11, 2018
• Primary Completion: May 3, 2019
• Study Completion: May 3, 2019
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)