Patients Undergoing Open Resection of Colorectal TumoursMaMiFloNCT02136277
Vascular Changes During Colorectal Surgery
An observational study of Patients Undergoing Open Resection of Colorectal Tumours, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether increases in the blood flow from the heart (the cardiac output), induced by the administration of intravenous fluids, lead to an increase in the blood flow to the vital organs, in patients undergoing bowel surgery. This study will involve 2 phases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients Undergoing Open Resection of Colorectal Tumours
- What is being tested?
- Hartmann's solution
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Jun 2016
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colorectal cancers, scheduled to undergo open resectional surgery.
Who may be able to join
- Aged 18 - 80 years
- Confirmed colorectal cancer
- Offered surgery by Derbyshire colorectal multidisciplinary team
- No metastatic disease
- Able to consent in English by themselves
Who cannot join
- Metastatic disease
- Oesophageal varices
- Patients with recent acute coronary syndrome (symptoms involving the heart) or unstable ischaemic cardiac disease (reduced blood supply to the heart);
- Patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs);
- Pregnant or breast-feeding women;
- Known sensitivity to Sonovue;
- Prolonged QT syndrome
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Derby Hospital
Derby, Derbyshire, DE22 3NE
John P Williams, PhD
David Read, BMBS
About this study
Official title: Measurement of Changes in Macro- and Microvascular Blood Flow During Major Colorectal Surgery
The purpose of this study is to investigate whether increases in the blood flow from the heart (the cardiac output), induced by the administration of intravenous fluids, lead to an increase in the blood flow to the vital organs, in patients undergoing bowel surgery.
This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the research fellow (medical doctor) undertaking this study, who will check their suitability to participate in the study and who will obtain informed consent.
Read more
The second phase is the study itself which will take place whilst volunteers are having their bowel operation. They will attend theatre in the normal way, but once they have been anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in bowel surgery to help assess how much intravenous fluid to administer to a patient by measuring the cardiac output (the amount of blood pumped out of the heart each minute). Using the cannula (drip) already inserted in the arm to allow administration of the anaesthetic, a special fluid, called an ultrasound contrast agent, will be injected into the drip, to allow a contrast enhanced ultrasound scan of the abdominal organs to be performed, to measure the blood flow to these organs. A small sample of blood will be taken from the earlobe to allow us to measure a chemical in the blood called lactate.
After this, intravenous fluid will be administered in order to increase the amount of blood pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate amount of fluid has been given, a second ultrasound scan will be performed to measure whether blood flow to the abdominal organs has also increased. A further blood sample will be taken from your earlobe to measure any change in lactate level.
At the completion of the operation, a third ultrasound scan will be performed and another sample of blood taken from the earlobe, to help assess blood flow to the organs.
Read the detailed description
Potential participants (patients with colorectal cancer offered an operation) will be highlighted from the Derbyshire NHS trusts colorectal multidisciplinary team meeting. All patients who fulfil entry requirements will be seen by the research fellow after their outpatient meeting with their particular surgeon (if they agree). Information packs containing details of the study (information sheet and consent form) will be given and any questions answered. Patients will be allowed to take the packs away with them and decide whether they would be keen to participate. Interested patients will be consented by the research fellow during their subsequent pre-operative clinic appointment.
The study will take place intra-operatively. Monitoring will be instituted as determined necessary by the attending anaesthetists, but as a minimum will consist of pulse oximetry, ECG and non-invasive blood pressure recording. Intravenous cannulae will be sited and general anaesthesia induced by the anaesthetist responsible for the patient, as would be normal for this type of surgery. Once the patient has been transferred to the operating theatre, the research fellow will insert an ODM probe via either the nasal or oral route and the CO and SV will be measured; this constitutes normal care. A sterile Phillips iU22 USS probe will be placed on the patient's abdomen and the research fellow will administer SonoVue contrast agent intravenously via the cannula already sited to facilitate anaesthesia, up to a maximum dose of 2.4ml. Visceral MVBF will be measured using this CEUS technique. Capillary blood samples will be taken from earlobe for measurement of blood lactate levels by the research fellow. At this stage, as would typically occur during an operation of this nature, the research fellow will administer intravenous colloid suspension in boluses of 3ml/kg, up to a maximum of 15ml/kg, until the CO has been maximised, as judged by the ODM. At this stage, the research fellow will perform a further CEUS of the abdominal viscera by administering Sonovue contrast agent (2nd dose of up to 2.4ml) and measuring MVBF with the Phillips iU22. Repeat samples of capillary blood will be drawn to measure the lactate level by the research fellow. At the end of the operation, a 3rd CEUS of the abdominal viscera, along with further SV \& CO readings, will be made.
- Being tested
- Hartmann's solution
- Keywords
- colorectal surgery, cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hartmann's solutionDrug
Also called Compound sodium lactate solution, Ringer's lactate solution, Lactated Ringer's solution
Administered in 250ml boluses, until cardiac output has been optimised.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal patients | Subjects undergoing colorectal surgery Receives: Drug: Hartmann's solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in microvascular blood flow during colorectal surgery
Measured: Immediately following optimisation of cardiac output
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Open Resection of Colorectal TumoursStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Heinink, University of Nottingham
- Investigators
- John P Williams, PhD, Study chair, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136277
- Sponsor's protocol ID
- 13115
- Acronym
- MaMiFlo
- Status last verified
- Jan 2015
- First submitted
- 8 May 2014
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Changes in Macro- and Microvascular Blood Flow During Major Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02136277
- Acronym / sponsor ID
- MaMiFlo / 13115
- Keywords
- colorectal surgery, cardiac output
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 12 May 2014 (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 purpose of this study is to investigate whether increases in the blood flow from the heart (the cardiac output), induced by the administration of intravenous fluids, lead to an increase in the blood flow to the vital organs, in patients undergoing bowel surgery.
This study will involve 2 phases. Firstly, potential volunteers will be invited to meet the research fellow (medical doctor) undertaking this study, who will check their suitability to participate in the study and who will obtain informed consent.
The second phase is the study itself which will take place whilst volunteers are having their bowel operation. They will attend theatre in the normal way, but once they have been anaesthetised (put to sleep), a special monitor called an oesophageal doppler probe will be placed into their oesophagus (food pipe) via the nose. This monitor is frequently used in bowel surgery to help assess how much intravenous fluid to administer to a patient by measuring the cardiac output (the amount of blood pumped out of the heart each minute). Using the cannula (drip) already inserted in the arm to allow administration of the anaesthetic, a special fluid, called an ultrasound contrast agent, will be injected into the drip, to allow a contrast enhanced ultrasound scan of the abdominal organs to be performed, to measure the blood flow to these organs. A small sample of blood will be taken from the earlobe to allow us to measure a chemical in the blood called lactate.
After this, intravenous fluid will be administered in order to increase the amount of blood pumped out of the heart. Once the oesophageal doppler monitor suggests that an adequate amount of fluid has been given, a second ultrasound scan will be performed to measure whether blood flow to the abdominal organs has also increased. A further blood sample will be taken from your earlobe to measure any change in lactate level.
At the completion of the operation, a third ultrasound scan will be performed and another sample of blood taken from the earlobe, to help assess blood flow to the organs.
Detailed description
Potential participants (patients with colorectal cancer offered an operation) will be highlighted from the Derbyshire NHS trusts colorectal multidisciplinary team meeting. All patients who fulfil entry requirements will be seen by the research fellow after their outpatient meeting with their particular surgeon (if they agree). Information packs containing details of the study (information sheet and consent form) will be given and any questions answered. Patients will be allowed to take the packs away with them and decide whether they would be keen to participate. Interested patients will be consented by the research fellow during their subsequent pre-operative clinic appointment.
The study will take place intra-operatively. Monitoring will be instituted as determined necessary by the attending anaesthetists, but as a minimum will consist of pulse oximetry, ECG and non-invasive blood pressure recording. Intravenous cannulae will be sited and general anaesthesia induced by the anaesthetist responsible for the patient, as would be normal for this type of surgery. Once the patient has been transferred to the operating theatre, the research fellow will insert an ODM probe via either the nasal or oral route and the CO and SV will be measured; this constitutes normal care. A sterile Phillips iU22 USS probe will be placed on the patient's abdomen and the research fellow will administer SonoVue contrast agent intravenously via the cannula already sited to facilitate anaesthesia, up to a maximum dose of 2.4ml. Visceral MVBF will be measured using this CEUS technique. Capillary blood samples will be taken from earlobe for measurement of blood lactate levels by the research fellow. At this stage, as would typically occur during an operation of this nature, the research fellow will administer intravenous colloid suspension in boluses of 3ml/kg, up to a maximum of 15ml/kg, until the CO has been maximised, as judged by the ODM. At this stage, the research fellow will perform a further CEUS of the abdominal viscera by administering Sonovue contrast agent (2nd dose of up to 2.4ml) and measuring MVBF with the Phillips iU22. Repeat samples of capillary blood will be drawn to measure the lactate level by the research fellow. At the end of the operation, a 3rd CEUS of the abdominal viscera, along with further SV \& CO readings, will be made.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal patients | – | Drug: Hartmann's solutionSubjects undergoing colorectal surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal cancers, scheduled to undergo open resectional surgery.
Key inclusion criteria (5 listed)
- Aged 18 - 80 years
- Confirmed colorectal cancer
- Offered surgery by Derbyshire colorectal multidisciplinary team
- No metastatic disease
- Able to consent in English by themselves
Key exclusion criteria (7 listed)
- Metastatic disease
- Oesophageal varices
- Patients with recent acute coronary syndrome (symptoms involving the heart) or unstable ischaemic cardiac disease (reduced blood supply to the heart);
- Patients known to have right-to-left shunts (abnormal movement of blood within the heart), severe pulmonary hypertension (high blood pressure in the pulmonary artery, the blood vessel that leads from the heart to the lungs), uncontrolled hypertension (high blood pressure) or adult respiratory distress syndrome (severe fluid build-up in both lungs);
- Pregnant or breast-feeding women;
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 |
|---|---|---|
| Hartmann's solutionAlso: Compound sodium lactate solution, Ringer's lactate solution, Lactated Ringer's solutionAdministered in 250ml boluses, until cardiac output has been optimised. | Drug | Colorectal patients |
Primary outcome
Changes in microvascular blood flow during colorectal surgery
Time frame: Immediately following optimisation of cardiac output
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
Related trials for Patients Undergoing Open Resection of Colorectal Tumours
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.
John P Williams, PhD study chair
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Open Resection of Colorectal Tumours, run by University of Nottingham at 1 site in United Kingdom.
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 5 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jan 2015. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John P Williams, PhD (01332 724641, john.williams7@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in microvascular blood flow during colorectal surgery (time frame: Immediately following optimisation of cardiac output). 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 27 Jan 2015.