Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients

NCT ID: NCT03768752

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-11

Study Completion Date

2019-05-03

Brief Summary

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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.

Detailed Description

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Conditions

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Sepsis Diastolic Dysfunction Lung Edema Fluid Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Diastolic Dysfunction

Patients with pre-existing or new diastolic dysfunction.

No interventions assigned to this group

Normal Diastolic Function

Patients with normal diastolic function.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Ursula Kahl

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ursula Kahl, MD

Role: PRINCIPAL_INVESTIGATOR

Klinik und Poliklinik für Anästhesie Universitätsklinikum Hamburg-Eppendorf

Locations

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Universitätskrankenhaus Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 26414292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12700374 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25800584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25656060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23825499 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8844239 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35845063 (View on PubMed)

Other Identifiers

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DD-Sepsis

Identifier Type: -

Identifier Source: org_study_id

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