Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure

Sepsis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03031275
• Other study ID #: 2013/2258-31/1
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 22, 2017
• Start date: January 2014

Study information

• Verified date: January 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska.

Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier.

Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary function testing, exercise tolerance, quality of life and mood disorder screening.

Description:

All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were screened for eligibility in January 2014. Patients living abroad (including non-Swedish citizens), patients treated for non-respiratory conditions, diseased patients and patients with a known pre-ECMO mental handicap were excluded.

Eligible patients were contacted, and patients who agreed to participate gave their written informed consent. All studied patients underwent the same study protocol during a day at the hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax, pulmonary function testing, neuropsychological examination, walking test, self assessment questionnaires for quality of life, anxiety, depression and post-traumatic stress.

Patient charts were reviewed for relevant clinical information, including age, gender, ECMO mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical ventilation; preexisting diseases, blood gas values and ventilator settings before initiation of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure, hemoglobin, lactate and oxygenation parameters during an observation period, which was defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10 days). This information was added to a digital database for the purpose of this study.

At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate and venous saturation values were used as indicators of sufficient (lactate < 2 mmol l-1 , SvO2 ≥ 70%) or insufficient tissue perfusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009

Exclusion Criteria:

• Diseased patients

• Patients living abroad (including non-Swedish citizens)

• Patients treated for non-respiratory conditions

• Patients with a known pre-ECMO mental handicap

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Cognition Disorders
• Cognitive Impairment
• Critical Illness
• Extracorporeal Circulation; Complications
• Long Term Adverse Effects
• Pneumonia
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis

Intervention

Radiation:
• High-resolution computed tomography
HRCT of the thorax
• Magnetic resonance imaging
MRI of the brain

Behavioral:
• Cognitive testing
Neuropsychological testing

Locations

Country	Name	City	State
Sweden	ECMO Center Karolinska	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests	Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.	5-17 years after treatment
Primary	Number of participants with abnormal brain imaging assessed by magnetic resonance imaging	Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.	5-17 years after treatment
Primary	Number of Participants With Abnormal Pulmonary function	Static and dynamic spirometry. Measured results as % of the expected normal values were presented.	5-17 years after treatment
Primary	Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan	Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.	5-17 years after treatment
Primary	Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire		5-17 years after treatment
Primary	Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36		5-17 years after treatment
Primary	Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire		5-17 years after treatment
Primary	Number of participants with signs of a reduced exercise tolerance	6-minute walking test	5-17 years after treatment
Primary	Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale		5-17 years after treatment