Hemolytic Uremic SyndromeEHEC-PEGNCT01561248
Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis
A study testing polyethylene glycol solution for daily bowel lavage. in people with Hemolytic Uremic Syndrome and Hemorrhagic Colitis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemolytic Uremic Syndrome, Hemorrhagic Colitis, Intestinal Infectious Disease
- What is being tested?
- polyethylene glycol solution for daily bowel lavage.
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Feb 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Proven EHEC O104:H4-infection
- Presence of bloody diarrhoea + at least one of the following serological criteria:
- platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) > 300 IU/l, leukocytosis ( > 12x10³/ μl ) and elevated CRP (> 5mg/l), hemoglobin < 13.8 g/dL for male patients or < 12.1 g/dL for female patients, respectively or decrease in haptoglobin
Who cannot join
- Bloody diarrhoea due to others reasons than EHEC O104:H4 infection
- Thrombocytopenia < 100x10³/ μl.
- HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for age
Trial locations and contacts
1 site in 1 country.
Germany1 site
1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Hamburg, Free and Hanseatic City of Hamburg, 20246
About this study
Official title: Repetitive Intestinal Lavage Using Polyethylene Glycol Solution in Patients With EHEC O104:H4 Infection During the German 2011 Outbreak for Prevention of Severe Thrombocytopenia With Subsequently Following Therapeutic Plasmapheresis
The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.
Read the detailed description
During the 2011 German EHEC O104:H4 outbreak, centered in the area of Hamburg, 33 patients with EHEC associated hemorrhagic colitis were admitted to the first Department of Medicine of the Hamburg University medical centre.
The first 12 patients were treated symptomatically and received intravenous rehydration up to three liters daily.
Prompted by a good clinical response after whole bowel irrigation with polyethylene glycol-solution (PEG)in patient 13 all subsequent admitted patients (n=21) were treated with PEG-solution ( 2 liters on admission followed by one liter per day during the clinical course).
During the hospital course blood work was obtained every day and patients were examined for clinical symptoms.
Thrombocytopenia below 100.000/microliter was defined as a threshold for initiating therapeutic plasmapheresis to prevent the onset of hemolytic syndrome on an early stage.
- Conditions
- Hemolytic Uremic Syndrome, Hemorrhagic Colitis, Intestinal Infectious Disease, Intestinal Infection Due to E. Coli
- Being tested
- polyethylene glycol solution for daily bowel lavage.
- Keywords
- EHEC, O104:H4, German, outbreak, polyethylene glycol, Bowel lavage
- Medical subject headings
- Hemolytic-Uremic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyethylene glycol solution for daily bowel lavage.Drug
Also called Klean-Prep(Norgine GmBH, Marburg, Germany).
At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course.
| Study group | Role | What they receive |
|---|---|---|
| SOC-treatment | No intervention | Patients with EHEC associated bloody diarrhoea (n=12) receiving standard of care treatment, consisting of intravenous fluids (2-3 liters/daily), analgetics, including paracetamol and metamizol and metoclopramid, if required. |
| PEG-Solution, daily bowel lavage | Experimental | Patients with EHEC associated bloody diarrhoea (n=21)receiving SOC-treatment, consisting of i.v. fluids (2-3 liter/day), analgetics ( paracetamol and metamizol) or metoclopramid and orally administered polyethylene glycol-solution daily during the clinical course. Receives: Drug: polyethylene glycol solution for daily bowel lavage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombocytopenia (Defined as platlet count below 100.000/microliter)
Following admission, blood samples were taken every day during the hospital course. When a platelet count below 100.000/microliter was measured, patients were subsequently transfered to the department of nephrology for therapeutic plasmapheresis.
As thrombocytopenia is the first abnormal laboratory finding in EHEC infected patients developing HUS, therapeutic plasmapheresis was initiated to prevent onset of mature HUS when thrombocytopenia (defined as mentioned above )was measured.
Measured: Patients will be followed for the duration of hospital stay, an expected average of two weeks
Secondary outcomes (1)
Duration of hospitalisation
Secondary outcome in this study was the duration of hospitalisation in the two groups. Duration of hospitalisation was assessed by reviewing the case notes.
Measured: Patients will be followed for the duration of hospital stay, an expected average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2012 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic Uremic SyndromeStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Lüth, M.D., Study director, Department of Medicine, University Medical Centre Hamburg-Eppendorf, HamburgThorben Fründt, M.D., Principal investigator, Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561248
- Sponsor's protocol ID
- EHEC-2011-PEG
- Acronym
- EHEC-PEG
- Status last verified
- Mar 2012
- First submitted
- 23 Jan 2012
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Intestinal Lavage Using Polyethylene Glycol Solution in Patients With EHEC O104:H4 Infection During the German 2011 Outbreak for Prevention of Severe Thrombocytopenia With Subsequently Following Therapeutic Plasmapheresis
- ClinicalTrials.gov ID
- NCT01561248
- Acronym / sponsor ID
- EHEC-PEG / EHEC-2011-PEG
- Conditions
- Hemolytic Uremic Syndrome, Hemorrhagic Colitis, Intestinal Infectious Disease, Intestinal Infection Due to E. Coli
- Keywords
- EHEC, O104:H4, German, outbreak, polyethylene glycol, Bowel lavage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 22 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.
Detailed description
During the 2011 German EHEC O104:H4 outbreak, centered in the area of Hamburg, 33 patients with EHEC associated hemorrhagic colitis were admitted to the first Department of Medicine of the Hamburg University medical centre.
The first 12 patients were treated symptomatically and received intravenous rehydration up to three liters daily.
Prompted by a good clinical response after whole bowel irrigation with polyethylene glycol-solution (PEG)in patient 13 all subsequent admitted patients (n=21) were treated with PEG-solution ( 2 liters on admission followed by one liter per day during the clinical course).
During the hospital course blood work was obtained every day and patients were examined for clinical symptoms.
Thrombocytopenia below 100.000/microliter was defined as a threshold for initiating therapeutic plasmapheresis to prevent the onset of hemolytic syndrome on an early stage.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC-treatment | No intervention | –Patients with EHEC associated bloody diarrhoea (n=12) receiving standard of care treatment, consisting of intravenous fluids (2-3 liters/daily), analgetics, including paracetamol and metamizol and metoclopramid, if required. |
| PEG-Solution, daily bowel lavage | Experimental | Drug: polyethylene glycol solution for daily bowel lavage.Patients with EHEC associated bloody diarrhoea (n=21)receiving SOC-treatment, consisting of i.v. fluids (2-3 liter/day), analgetics ( paracetamol and metamizol) or metoclopramid and orally administered polyethylene glycol-solution daily during the clinical course. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Proven EHEC O104:H4-infection
- platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) > 300 IU/l, leukocytosis ( > 12x10³/ μl ) and elevated CRP (> 5mg/l), hemoglobin < 13.8 g/dL for male patients or < 12.1 g/dL for female patients, respectively or decrease in haptoglobin
Key exclusion criteria (3 listed)
- Bloody diarrhoea due to others reasons than EHEC O104:H4 infection
- Thrombocytopenia < 100x10³/ μl.
- HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyethylene glycol solution for daily bowel lavage.Also: Klean-Prep(Norgine GmBH, Marburg, Germany).At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course. | Drug | PEG-Solution, daily bowel lavage |
Primary outcome
Thrombocytopenia (Defined as platlet count below 100.000/microliter)
Time frame: Patients will be followed for the duration of hospital stay, an expected average of two weeks
Following admission, blood samples were taken every day during the hospital course. When a platelet count below 100.000/microliter was measured, patients were subsequently transfered to the department of nephrology for therapeutic plasmapheresis. As thrombocytopenia is the first abnormal laboratory finding in EHEC infected patients developing HUS, therapeutic plasmapheresis was initiated to prevent onset of mature HUS when thrombocytopenia (defined as mentioned above )was measured.
1 secondary outcome
Duration of hospitalisation
Time frame: Patients will be followed for the duration of hospital stay, an expected average of two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Lüth, M.D. study director
Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Thorben Fründt, M.D. principal investigator
Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyethylene glycol solution for daily bowel lavage. in people with Hemolytic Uremic Syndrome and Hemorrhagic Colitis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombocytopenia (Defined as platlet count below 100.000/microliter) (time frame: Patients will be followed for the duration of hospital stay, an expected average of two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2012.