Clinical trial NCT03768752: Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients
Official title: Left Ventricular Diastolic Dysfunction as a Risk Factor for Interstitial Lung Edema in Septic Patients on the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Diastolic Dysfunction
Lung Edema
Fluid Overload
Keywords: intensive care unit
echocardiography
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients on the intensive care unit of the university hospital Hamburg-Eppendorf diagnosed with sepsis.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Diastolic Dysfunction
timeFrame: While in septic condition, up to 10 days maximum.
measure: Pulmonary Edema
timeFrame: While in septic condition, up to 10 days maximum.
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätskrankenhaus Hamburg-Eppendorf
Study officials:
affiliation: Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf
name: Ursula Kahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.