Postoperative InflammationNCT01880190
A Comparative Study of Volume Replacement With HES 130/0.4 Versus Ringer's Lactate (RL) Regarding Their Effects on Inflammatory Biomarkers (Cytokines and Matrix Metalloproteinases) Responses to Major Abdominal Surgery.
A study testing Ringer's Lactate and HES 130/0.4 and Ringer's Lactate in people with Postoperative Inflammation, run by Paraskevi Matsota at 1 site in Greece.
Trial summary
Various stimuli such as trauma, infection and major surgery may alter the physiologic immune balance and initiate systemic inflammatory processes. This pathophysiological event is characterized by the release of potent inflammatory mediators into the circulation. Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Inflammation
- What is being tested?
- Ringer's Lactate and HES 130/0.4 and Ringer's Lactate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteGreece
- Study dates
- Dec 2008to Apr 2010
- 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 18 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiologists) I and ASA II
Who cannot join
- cardiac insufficiency ( > New York Heart Association (NYHA) class II)
- renal insufficiency (serum creatinine > 200μm/L)
- severe pulmonary disease (chronic obstructive lung disease, PaO2 < 70 mmHg when FiO2= 0.21)
- liver disfunction (AST > 40 U/L, ALT > 40 U/L)
- diabetes mellitus
- autoimmune disease
Show all 13Show fewer
- pre-existing signs of bacterial (WBC > 10000, body temperature > 38.0 C)or viral infection (HBV, HCV, HIV, CMV)
- pre-existing signs of active inflammation (CRP > 4)
- malignant neoplasia
- morbid obesity
- patients in extreme muscular activity (athletes)
- patients with chronic use of corticosteroids or β- blockers or non-steroid anti-inflammatory substances
- known allergic reactions to colloids solutions
Trial locations and contacts
1 site in 1 country.
Greece1 site
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attica, 12462
About this study
Official title: Volume Replacement With HES 130/0.4 Attenuates Inflammatory Response to Major Abdominal Surgery Compared to Ringer's Lactate (RL); the Effect on Cytokines and Matrix Metalloproteinases
Various stimuli such as trauma, infection and major surgery may alter the physiologic immune balance and initiate systemic inflammatory processes. This pathophysiological event is characterized by the release of potent inflammatory mediators into the circulation.
Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs) in the inflammatory response. The MMPs constitute a family of enzymes that are structurally related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM) components and play an important role in wound healing and remodeling of the ECM. The Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.
Read more
The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many factors may attributed to this response, such as the kind of operation, the extent of surgical trauma, the patient's medical history and therapy, as well as the type of anesthesia used. Apart from that, the kind of fluids administered for volume replacement was revealed to alter the inflammatory processes. Several studies have addressed on this issue mainly involved abdominal surgery and provided compelling evidence that perioperative fluid optimization produces benefits for the patient, with regard to inflammatory biomarkers such as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They support that the different volume replacement strategies, using only crystalloids or combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune response. However, the relevant studies investigated different inflammatory biomarkers, and usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.
In our study we investigated the hypothesis that intra- and postoperative volume replacement with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1, cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated postoperatively. Their changes during the first 24 postoperative hours consisted our primary outcomes.
- Conditions
- Postoperative Inflammation
- Being tested
- Ringer's Lactate, HES 130/0.4 and Ringer's Lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactateOther
HES 130/0.4 and Ringer's LactateOther
| Study group | Role | What they receive |
|---|---|---|
| Ringer's Lactate | Active comparator | Crystalloid solution Receives: Other: Ringer's Lactate |
| HES 130/0.4 and Ringer's Lactate | Active comparator | Colloid solution Receives: Other: HES 130/0.4 and Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of inflammatory biomarkers (MMP-9, MMP-13, TIMP-1, IL-6, IL-8 ICAM-1) in abdominal surgery.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startDec 2008
- Primary completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InflammationStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paraskevi Matsota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paraskevi Matsota, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880190
- Sponsor's protocol ID
- 301
- Status last verified
- Jul 2013
- First submitted
- 14 Jun 2013
- Last updated
- 15 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volume Replacement With HES 130/0.4 Attenuates Inflammatory Response to Major Abdominal Surgery Compared to Ringer's Lactate (RL); the Effect on Cytokines and Matrix Metalloproteinases
- ClinicalTrials.gov ID
- NCT01880190
- Acronym / sponsor ID
- 301
- Conditions
- Postoperative Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Paraskevi MatsotaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Apr 2010 (actual)
- First posted
- 18 Jun 2013 (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.
Various stimuli such as trauma, infection and major surgery may alter the physiologic immune balance and initiate systemic inflammatory processes. This pathophysiological event is characterized by the release of potent inflammatory mediators into the circulation.
Among these, pro- and anti-inflammatory cytokines such as interleukin-6 (IL-6), IL-8 or IL-10, ICAM-1 play a dominant role as local or systemic regulators in the acute inflammatory response. Recent studies have also investigated the role of matrix metalloproteinases (MMPs) in the inflammatory response. The MMPs constitute a family of enzymes that are structurally related neutral proteinases. MMPs can degrade essentially all extracellular matrix (ECM) components and play an important role in wound healing and remodeling of the ECM. The Tissutal Inhibitor MetalloProteine (TIMPs) are important regulator of MMPs activity.
The inflammatory response coming of surgery mainly affects surgical patients' outcome. Many factors may attributed to this response, such as the kind of operation, the extent of surgical trauma, the patient's medical history and therapy, as well as the type of anesthesia used. Apart from that, the kind of fluids administered for volume replacement was revealed to alter the inflammatory processes. Several studies have addressed on this issue mainly involved abdominal surgery and provided compelling evidence that perioperative fluid optimization produces benefits for the patient, with regard to inflammatory biomarkers such as cytokines, matrix metalloproteinases, intercellular adhesion molecule-1(ICAM-1). They support that the different volume replacement strategies, using only crystalloids or combination of crystalloids with colloids (HES 130/0,4), may have important impact on immune response. However, the relevant studies investigated different inflammatory biomarkers, and usually involved either metalloproteinases, and their inhibitors (TIMPs) or cytokines.
In our study we investigated the hypothesis that intra- and postoperative volume replacement with HES attenuates inflammatory response to elective abdominal surgery compared to RL fluid therapy. For this purpose both metalloproteinases, MMP-9, MMP-13, their inhibitor, TIMP-1, cytokines, IL-6, IL-8 and the intercellular adhesion molecule-1, ICAM-1 were investigated postoperatively. Their changes during the first 24 postoperative hours consisted our primary outcomes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer's Lactate | Active comparator | Other: Ringer's LactateCrystalloid solution |
| HES 130/0.4 and Ringer's Lactate | Active comparator | Other: HES 130/0.4 and Ringer's LactateColloid solution |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA (American Society of Anesthesiologists) I and ASA II
Key exclusion criteria (13 listed)
- cardiac insufficiency ( > New York Heart Association (NYHA) class II)
- renal insufficiency (serum creatinine > 200μm/L)
- severe pulmonary disease (chronic obstructive lung disease, PaO2 < 70 mmHg when FiO2= 0.21)
- liver disfunction (AST > 40 U/L, ALT > 40 U/L)
- diabetes mellitus
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 |
|---|---|---|
| Ringer's Lactate | Other | Ringer's Lactate |
| HES 130/0.4 and Ringer's Lactate | Other | HES 130/0.4 and Ringer's Lactate |
Primary outcome
Measurement of inflammatory biomarkers (MMP-9, MMP-13, TIMP-1, IL-6, IL-8 ICAM-1) in abdominal surgery.
Time frame: 24 hours postoperatively
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 15 Jul 2013.
Related trials for Postoperative Inflammation
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Recruiting
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Recruiting
Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery
Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Breast Cancer
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Lactate and HES 130/0.4 and Ringer's Lactate in people with Postoperative Inflammation, run by Paraskevi Matsota at 1 site in Greece.
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 1 inclusion and 13 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 15 Jul 2013. 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 Greece. 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?
Measurement of inflammatory biomarkers (MMP-9, MMP-13, TIMP-1, IL-6, IL-8 ICAM-1) in abdominal surgery. (time frame: 24 hours postoperatively). 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 15 Jul 2013.