Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

Sepsis Clinical Trial

Official title:

Left Ventricular Diastolic Dysfunction as a Risk Factor for Interstitial Lung Edema in Septic Patients on the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768752
• Other study ID #: DD-Sepsis
• Status: Completed
• Start date: October 11, 2018
• Est. completion date: May 3, 2019

Study information

• Verified date: May 2021
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 3, 2019
• Est. primary completion date: May 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Edema
• Fluid Overload
• Lung Edema
• Pulmonary Edema
• Sepsis

Locations

Country	Name	City	State
Germany	Universitätskrankenhaus Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Enghard P, Rademacher S, Nee J, Hasper D, Engert U, Jörres A, Kruse JM. Simplified lung ultrasound protocol shows excellent prediction of extravascular lung water in ventilated intensive care patients. Crit Care. 2015 Feb 6;19:36. doi: 10.1186/s13054-015-0756-5. — View 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. — View 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. — View 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. Review. Erratum in: Intensive Care Med. 2015 Jun;41(6):1178-9. — View 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. — View Citation

Vincent JL, Moreno R, Takala J, Willatts S, De Mendonça 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.