Clinical Trials Logo
  1. Home
  2. Septic Shock
  3. NCT02961166
  4. Details
NCT02961166 Clinical Trial

Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients

Septic Shock Clinical Trial

— IVIG  

Official title:
Intravenous Immunoglobulin Therapy in ARDS Patients With Extracorporeal Membrane Oxygenation (ECMO) Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02961166
Other study ID # University Hospital Tuebingen
Secondary ID
Status Completed
Phase
First received May 8, 2016
Last updated April 20, 2018
Start date January 2012
Est. completion date May 2016

Study information
Verified date April 2018
Source University Hospital Tuebingen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received immunglobulin M-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.

These patients were analyzed regarding length of stay in intensive care unit (LOS ICU), length of stay (LOS) in hospital and regarding mortality.

Description:

57 patients with ARDS requiring ECMO therapy were analyzed retrospectively. 28 patients had received IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.

Patient characteristics, like Acute Physiology And Chronic Health Evaluation (APACHE) and Sepsis-related organ failure assessment (SAPS) Score, preexisting diseases, origin of infection, duration of ECMO therapy were analyzed in these patients.

These patients were further analyzed regarding LOS ICU, LOS in hospital and regarding mortality.

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date May 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All data available

- ARDS with ECMO therapy

Exclusion Criteria:

- Data missing

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• IgM enriched Immunoglobulins
Treatment for 3 days

Locations
Country Name City State
Germany University Hospital Tuebingen Tuebingen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Tuebingen Universität Tübingen

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Death during ICU therapy during ICU treatment, up to 28 days
Secondary lengh of stay (LOS ICU) lengh of stay on ICU in days up to 60 days
See also
  Status Clinical Trial Phase
Recruiting NCT03649633 - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock Phase 1/Phase 2
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Completed NCT05629780 - Temporal Changes of Lactate in CLASSIC Patients N/A
Recruiting NCT04796636 - High-dose Intravenous Vitamin C in Patients With Septic Shock Phase 1
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02676427 - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Recruiting NCT02565251 - Volemic Resuscitation in Sepsis and Septic Shock N/A
Recruiting NCT02580240 - Administration of Hydrocortisone for the Treatment of Septic Shock N/A
Not yet recruiting NCT02547467 - TOADS Study: TO Assess Death From Septic Shock. N/A
Completed NCT02638545 - Hemodynamic Effects of Dexmedetomidine in Septic Shock Phase 3
Terminated NCT02335723 - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber N/A
Completed NCT02079402 - Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Phase 4
Completed NCT02204852 - Co-administration of Iloprost and Eptifibatide in Septic Shock Patients Phase 2