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CompletedNCT03768752Updated May 14, 2021

Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

An observational study in Sepsis, Diastolic Dysfunction and Lung Edema, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-14.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
83
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sepsis
  • Diastolic Dysfunction
  • Lung Edema
  • Fluid Overload

Keywords

  • intensive care unit
  • echocardiography
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In context

Pulmonary Edema

138 studies on the registry are indexed under Pulmonary Edema; 24 are open to participants now.

This study's enrollment of 83 is below the median of 118 across 57 observational studies indexed under Pulmonary Edema.

Browse Pulmonary Edema studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
83 participants (actual)
Patient registry
No

Groups and cohorts

  • Diastolic Dysfunction

    Patients with pre-existing or new diastolic dysfunction.

  • Normal Diastolic Function

    Patients with normal diastolic function.

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What researchers measure

Primary outcomes

  1. Diastolic Dysfunction

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

    Time frame: While in septic condition, up to 10 days maximum.

  2. 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).

    Time frame: While in septic condition, up to 10 days maximum.

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Study locations

1 site
  • Universitätskrankenhaus Hamburg-Eppendorf
    Hamburg, 20246, Germany
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References and documents

Publications

  • 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. PubMed 26414292 ↗
  • 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. PubMed 12700374 ↗
  • 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. Erratum In: Intensive Care Med. 2015 Jun;41(6):1178-9. doi: 10.1007/s00134-015-3799-9. PubMed 25800584 ↗
  • 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. PubMed 25656060 ↗
  • 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. PubMed 23825499 ↗
  • 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. PubMed 8844239 ↗
  • 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. PubMed 35845063 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03768752
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
Responsible party
Ursula Kahl (Dr. med., Universitätsklinikum Hamburg-Eppendorf) — Principal investigator
First posted
Dec 7, 2018
Start date
Oct 11, 2018
Primary completion
May 3, 2019
Completion
May 3, 2019
Last update
May 14, 2021

Study contacts

Ursula Kahl, MD
principal investigator · Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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