Metabolic AcidosisPOKACIDNCT01860001
Incidence of Postoperative Ketosis and Metabolic Acidosis
An observational study of Metabolic Acidosis, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to define the incidence and nature of acidosis after major surgery using Figge's equations to directly measure acidosis. This study will also aim to compare the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to identify the presence of tissue acids in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Acidosis
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to Aug 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hospital patients seen in pre-operative assessment clinic
Who may be able to join
- Patients who have undergone major cancer surgery
- Patients who have an arterial line in place
- Patients who have a urinary catheter in place
- Patients who will be admitted to intensive care following surgery
- Adults >18 years
- Adults who are capable of reading and understanding English
Who cannot join
- Patient refusal
- Patients without an arterial line or urinary catheter in place
- Patients receiving glucose / sliding scale insulin for management of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
London, England, SW3 6JJ
Timothy Wigmore, 02073528171 ext. 1968, timothy.wigmore@rmh.nhs.uk
Shaman Jhanji, 02073528171, shaman.jhanji@rmh.nhs.uk
About this study
The aim of this study is to define the incidence and nature of acidosis after major surgery using Figge's equations to directly measure acidosis. This study will also aim to compare the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.
Read the detailed description
Metabolic acidosis is a frequent occurrence following major surgery. Monitoring acid base disturbances and in particular diagnosing the aetiology of the acidosis are important parts of assessing a patient's cardiovascular status following surgery. The presence of a metabolic acidosis is frequently attributed to anaerobic metabolism leading to the generation of lactic acid due to hypovolaemia and poor tissue perfusion. This commonly results in clinicians treating postoperative patients with a metabolic acidosis by administering intravenous fluids containing 0.9% saline or Hartmann's solution (compound sodium lactate). If the cause of the metabolic acidosis is not hypovolaemia, treatment with intravenous fluids may actually exacerbate the acidosis by causing hyperchloraemia. An often overlooked cause of metabolic acidosis after surgery is starvation leading to ketoacidosis. All patients are starved for a minimum of six hours prior to general anaesthesia due to the potential risk of aspiration of gastric contents into the bronchial tree. Many patients are in fact fasted for much longer periods than this. There is, however, little data describing the incidence of ketoacidosis following surgery. In addition, there may be other causes of acidosis after surgery which often overlooked but can be determined using equations and mathematical models. The aim of this study is to define the incidence and nature of acidosis after major cancer surgery using using equations to directly determine acids. This study will also aim to compare the ability of commonly used indirect measures (base deficit, anion gap, corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.
- Conditions
- Metabolic Acidosis
- Keywords
- cancer, metabolic acidosis
- Medical subject headings
- Acidosis, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery
Measured: 31/08/13
Secondary outcomes (1)
Incidence of metabolic acidosis, defined by base deficit . 2 mEq/L (Henderson-Hasselback) within one hour of completion of surgery.
Measured: 31/08/13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic AcidosisStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Wigmore, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860001
- Sponsor's protocol ID
- CCR3828
- Acronym
- POKACID
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Ketosis and Metabolic Acidosis
- ClinicalTrials.gov ID
- NCT01860001
- Acronym / sponsor ID
- POKACID / CCR3828
- Conditions
- Metabolic Acidosis
- Keywords
- cancer, metabolic acidosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 22 May 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.
The aim of this study is to define the incidence and nature of acidosis after major surgery using Figge's equations to directly measure acidosis. This study will also aim to compare the ability of indirect measures (base deficit, anion gap,corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.
Detailed description
Metabolic acidosis is a frequent occurrence following major surgery. Monitoring acid base disturbances and in particular diagnosing the aetiology of the acidosis are important parts of assessing a patient's cardiovascular status following surgery. The presence of a metabolic acidosis is frequently attributed to anaerobic metabolism leading to the generation of lactic acid due to hypovolaemia and poor tissue perfusion. This commonly results in clinicians treating postoperative patients with a metabolic acidosis by administering intravenous fluids containing 0.9% saline or Hartmann's solution (compound sodium lactate). If the cause of the metabolic acidosis is not hypovolaemia, treatment with intravenous fluids may actually exacerbate the acidosis by causing hyperchloraemia. An often overlooked cause of metabolic acidosis after surgery is starvation leading to ketoacidosis. All patients are starved for a minimum of six hours prior to general anaesthesia due to the potential risk of aspiration of gastric contents into the bronchial tree. Many patients are in fact fasted for much longer periods than this. There is, however, little data describing the incidence of ketoacidosis following surgery. In addition, there may be other causes of acidosis after surgery which often overlooked but can be determined using equations and mathematical models. The aim of this study is to define the incidence and nature of acidosis after major cancer surgery using using equations to directly determine acids. This study will also aim to compare the ability of commonly used indirect measures (base deficit, anion gap, corrected anion gap and lactate) to identify the presence of tissue acids in this population. The incidence of postoperative ketoacidosis as a contributor to tissue acidosis will be assessed through the use of point of care urinalysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hospital patients seen in pre-operative assessment clinic
Key inclusion criteria (6 listed)
- Patients who have undergone major cancer surgery
- Patients who have an arterial line in place
- Patients who have a urinary catheter in place
- Patients who will be admitted to intensive care following surgery
- Adults >18 years
Key exclusion criteria (3 listed)
- Patient refusal
- Patients without an arterial line or urinary catheter in place
- Patients receiving glucose / sliding scale insulin for management of 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.
Primary outcome
Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery
Time frame: 31/08/13
1 secondary outcome
Incidence of metabolic acidosis, defined by base deficit . 2 mEq/L (Henderson-Hasselback) within one hour of completion of surgery.
Time frame: 31/08/13
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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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.
Timothy Wigmore principal investigator
Royal Marsden NHS Foundation Trust
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 Metabolic Acidosis, run by Royal Marsden NHS Foundation Trust 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 6 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: status not confirmed, as of the sponsor's last update on 22 May 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 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 Timothy Wigmore, BM BCH (02073528181 ext. 1968, timothy.wigmore@rmh.nhs.ukl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of tissue acidosis, defined as tissue acids > 5mEq/L (Figge's equation) within one hour of completion of surgery (time frame: 31/08/13). 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 May 2013.