Albumin; DoubleALB-CIRNCT03643523
Determination of Albumina as an Early Predictor of Postoperative Infections in Colorectal Surgery
An observational study of Albumin; Double, run by Corporacion Parc Tauli.
Trial summary
Colorectal surgery has traditionally been associated with significant morbidity and prolonged hospital stay. Overall complication rates have been reported to be 26-35%. Infectious complications, in particular, represent a major cause of morbidity and mortality after colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Albumin; Double
- What is being tested?
- Albumine detection
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2019to 31 Dec 2019
- 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: Patients operated on scheludec colorectal surgery with primary anastomosis
Who may be able to join
- Patients older than 18 years
- Patients undergoing major colorectal surgery (expected to last 2 hours or more)
- Performing primary anastomosis
- Scheluded surgery
- Patients who give their written informed consent
Who cannot join
- Patients not meeting inclusion criteria at any time during the study (surgeries lasting less than 2 hours or anastomosis not performed. urgent surgery, not give written informed consent) will be excluded.
- No other inclusion or exclusion criteria have been considered, however, the investigator should consider any circumstance where the benefit-risk for the patient is not adequate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Study on the Determination of Albumina as an Early Predictor of Anastomotic Leak and Postoperative Infectious Complications in Colorectal Surgery
Colorectal surgery has traditionally been associated with significant morbidity and prolonged hospital stay. Overall complication rates have been reported to be 26-35%. Infectious complications, in particular, represent a major cause of morbidity and mortality after colorectal surgery. Postoperative intra-abdominal infections after colorectal surgery are mainly due to anastomotic leakage. They occur in 5 to 15% of patients and carry a short term mortality of around 20%. They also have a major impact on the outcome of surgery as they prolong in hospital stay, increase treatment costs and worsen long-term survival in cancer patients. If diagnosed early, they can be treated effectively and their impact on surgery outcome is thus minimised.
There is a growing interest to find a biological marker useful for early detection of anastomotic leak; such a marker could play a pivotal role in the modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery.
Read more
Although C reactive protein (CRP) and procalcitonin (PCT) have been proposed as predictors for adverse outcomes in colorectal surgery, they both display the critical limitations of slow kinetics. Conversely, serum albumin (ALB) is a maintenance protein that is rapidly down regulated by inflammatory signals. There some studies about the use of postoperative ALB drop as a marker of predictor for clinical outcome. These studies are either retrospective or mix patients with different types of surgical procedures performed.
This study aimed to test the hypotheses that early postoperative albumin drop can predict anastomotic leaks and also can predict postoperative infectious complications earlier than other biological markers.
Read the detailed description
Colorectal surgery (CS) has traditionally been associated with significant morbidity and prolonged hospital stay 1,2. Overall complication rates have been reported to be 26-35%.3,4,5,6 Infectious complications represent a major cause of morbidity and mortality after CS.6 Postoperative intra-abdominal infections after CS are mainly due to anastomotic leak (AL).7,8 They occur in 5 to 15% of patients and carry a short term mortality of around 20%.3 They also have a major impact on the outcome of surgery as they prolong in-hospital stay, increase treatment costs and worsen long-term survival in cancer patients.9,10,11 If diagnosed early, they can be treated effectively and their impact on surgery outcome is thus minimised.9 It is well-known that clinical features are not accurate predictors of AL in gastrointestinal surgery. 12,13 The white blood cell count is an unreliable predictor of either intra-abdominal infection or global postoperative infections. Routine imagine for the detection of leaks is not cost-effective and carries the drawback of radiation. Is it therefore essential to identify an early marker of infection, particularly in the era of "fast track" or "enhanced recovery " surgery, in which patients are discharged from hospital soon after operation, with the risk of intra-abdominal infection becoming evident after discharge thus inducing readmissions and late management.14 Althouhg early diagnosis of AL is a key point in reducing its clinical consequences in terms of morbidity and mortality, currently, AL diagnosis is often late because of misdiagnosis of medical complications and false-negative radiological examinations.15,16 Although C reactive protein (CRP) and procalcitonin (PCT) have been proposed as predictors for adverse outcomes in CS, they both display the critical limitations of slow kinetics.17,18,19 Conversely, serum albumin (ALB) is a maintenance protein that is rapidly down regulated by inflammatory signals. , Preliminary data suggested that ALB level rapidly dropped after surgery and correlated to outcomes in oesophageal, oral cancer, abdominal20 pancreatic, liver resection /trasplant and cardiac surgeries. However, prospective validation is missing, and ALB is not used to assess surgical stress or to predict outcomes.
Protein metabolism is significantly disturbed after any kind of traumatic event, for example, surgery, sepsis, and burn injuries , ALB has been identifyed as a reliable indicator of this process.21 Plasma concentration of ALB reveal an important decrease as early as a few hours after the hit.21,22,23 A previous studies estimated that 77% of the postoperative ALB decrease was due to redistribution, while 18% and 6% were attributed to blood loss and catabolism, respectively.24 Of note, transcapillary exchange rate early depended on the underlying trauma and no increase was noted after minor surgery.25,26 After operation, proinflamatory cytokines increase because of surgical stress, which leads to the reaction of circulating acute phase proteins, such as CRP and inteleukin-6, which have been widely use to predict complications after colorectal surgery.20 ALB, which is a marker of nutritional status and a negative acute phase protein, decreases immediately after surgery because of the physiological response to trauma. Increased capillary leakage of ALB is also one of the features of the systemic inflammatory response to surgical stress, which leads to a decreased level of plasma albumin. The response of ALB to surgical stress might occur earlier than CRP because ALB has quick kinetics after surgery.
There some studies about the use of postoperative ALB drop as a marker of predictor for clinical outcome. The first one, Hübner and col.21 shows a prospective pilot study about 70 patients undergoing frequent abdominal procedures of different magnitude. They measured ALB, CRP and CPT once daily starting the day before surgery until postoperative day (POD) 5. The conclusion of the estudy was that early postoperative ALB drop appeared to reflect the magnitud of surgical trauma and was correlated with adverse clinical outcomes. The group continues the same line of work and publishes another prospective cohort study with 138 patients undergoing major abdominal surgery. They collect blood samples before and on POD 0,1,2 and 3. They compare ALB decrease and CPR and CPT. The postoperative outcomes of the study were complications and length of hospital stay. They found a decrease of ALB of 10% yielded a sensitivity of 77.1% and a specificity of 67.2% (AUC : 78.3%) to predict complications. On the other hand, they also found that decrease of ALB of 10% on POD1 showed a threefold increased risk of overall postoperative complications.21 Antoher group, Ge et al.27 made a retrospective study about 626 patients undergoing major colorectal surgery with the main outcome were to identify risk factors for postoperative complications and to identify the factors associated with the ALB decrease. This study revealed the patients with a greater relative decrease in serum ALB in POD 2 were at higher risk of postoperative complications, prolonged postoperative hospital stays, an more Surgical Site infeccions after colorectal surgery. A cutoff value of 15% reduction in serum ALB on POD 2 distinguished patients at low risk and high risk for postoperative complications in an earlier stage and was more accurate the CRP level on POD 3 and 4.
These are the preliminary data that lead us to start our study in order to demonstrate the utility of the postoperative decrease of serum albumin as an early detector of anastomotic leak and infectious complications in patients undergoing major colorectal surgery This study aimed to test the hypotheses that early postoperative albumin drop can predict anastomotic leaks and also can predict postoperative infectious complications earlier than other biological markers
- Conditions
- Albumin; Double
- Being tested
- Albumine detection
- Keywords
- anastomitic leak, infectious complications, colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumine detectionDiagnostic test
Control of serum albumine levels in postoperatori of colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| ALbumin level | Detection of serum albumin levels in postoperatory of colorectal surgery Receives: Diagnostic Test: Albumine detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of serum albumine levels
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start15 Jan 2019 (estimated)
- Primary completion1 Feb 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Albumin; DoubleStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mora-Lopez, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643523
- Sponsor's protocol ID
- ALB-CIR
- Acronym
- ALB-CIR
- Status last verified
- Aug 2018
- First submitted
- 21 Aug 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Determination of Albumina as an Early Predictor of Anastomotic Leak and Postoperative Infectious Complications in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT03643523
- Acronym / sponsor ID
- ALB-CIR / ALB-CIR
- Conditions
- Albumin; Double
- Keywords
- anastomitic leak, infectious complications, colorectal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 15 Jan 2019 (estimated)
- Primary completion
- 1 Feb 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
Colorectal surgery has traditionally been associated with significant morbidity and prolonged hospital stay. Overall complication rates have been reported to be 26-35%. Infectious complications, in particular, represent a major cause of morbidity and mortality after colorectal surgery. Postoperative intra-abdominal infections after colorectal surgery are mainly due to anastomotic leakage. They occur in 5 to 15% of patients and carry a short term mortality of around 20%. They also have a major impact on the outcome of surgery as they prolong in hospital stay, increase treatment costs and worsen long-term survival in cancer patients. If diagnosed early, they can be treated effectively and their impact on surgery outcome is thus minimised.
There is a growing interest to find a biological marker useful for early detection of anastomotic leak; such a marker could play a pivotal role in the modern fast-track multimodal protocols, allowing safe and early discharge of patients after colorectal surgery.
Although C reactive protein (CRP) and procalcitonin (PCT) have been proposed as predictors for adverse outcomes in colorectal surgery, they both display the critical limitations of slow kinetics. Conversely, serum albumin (ALB) is a maintenance protein that is rapidly down regulated by inflammatory signals. There some studies about the use of postoperative ALB drop as a marker of predictor for clinical outcome. These studies are either retrospective or mix patients with different types of surgical procedures performed.
This study aimed to test the hypotheses that early postoperative albumin drop can predict anastomotic leaks and also can predict postoperative infectious complications earlier than other biological markers.
Detailed description
Colorectal surgery (CS) has traditionally been associated with significant morbidity and prolonged hospital stay 1,2. Overall complication rates have been reported to be 26-35%.3,4,5,6 Infectious complications represent a major cause of morbidity and mortality after CS.6 Postoperative intra-abdominal infections after CS are mainly due to anastomotic leak (AL).7,8 They occur in 5 to 15% of patients and carry a short term mortality of around 20%.3 They also have a major impact on the outcome of surgery as they prolong in-hospital stay, increase treatment costs and worsen long-term survival in cancer patients.9,10,11 If diagnosed early, they can be treated effectively and their impact on surgery outcome is thus minimised.9 It is well-known that clinical features are not accurate predictors of AL in gastrointestinal surgery. 12,13 The white blood cell count is an unreliable predictor of either intra-abdominal infection or global postoperative infections. Routine imagine for the detection of leaks is not cost-effective and carries the drawback of radiation. Is it therefore essential to identify an early marker of infection, particularly in the era of "fast track" or "enhanced recovery " surgery, in which patients are discharged from hospital soon after operation, with the risk of intra-abdominal infection becoming evident after discharge thus inducing readmissions and late management.14 Althouhg early diagnosis of AL is a key point in reducing its clinical consequences in terms of morbidity and mortality, currently, AL diagnosis is often late because of misdiagnosis of medical complications and false-negative radiological examinations.15,16 Although C reactive protein (CRP) and procalcitonin (PCT) have been proposed as predictors for adverse outcomes in CS, they both display the critical limitations of slow kinetics.17,18,19 Conversely, serum albumin (ALB) is a maintenance protein that is rapidly down regulated by inflammatory signals. , Preliminary data suggested that ALB level rapidly dropped after surgery and correlated to outcomes in oesophageal, oral cancer, abdominal20 pancreatic, liver resection /trasplant and cardiac surgeries. However, prospective validation is missing, and ALB is not used to assess surgical stress or to predict outcomes.
Protein metabolism is significantly disturbed after any kind of traumatic event, for example, surgery, sepsis, and burn injuries , ALB has been identifyed as a reliable indicator of this process.21 Plasma concentration of ALB reveal an important decrease as early as a few hours after the hit.21,22,23 A previous studies estimated that 77% of the postoperative ALB decrease was due to redistribution, while 18% and 6% were attributed to blood loss and catabolism, respectively.24 Of note, transcapillary exchange rate early depended on the underlying trauma and no increase was noted after minor surgery.25,26 After operation, proinflamatory cytokines increase because of surgical stress, which leads to the reaction of circulating acute phase proteins, such as CRP and inteleukin-6, which have been widely use to predict complications after colorectal surgery.20 ALB, which is a marker of nutritional status and a negative acute phase protein, decreases immediately after surgery because of the physiological response to trauma. Increased capillary leakage of ALB is also one of the features of the systemic inflammatory response to surgical stress, which leads to a decreased level of plasma albumin. The response of ALB to surgical stress might occur earlier than CRP because ALB has quick kinetics after surgery.
There some studies about the use of postoperative ALB drop as a marker of predictor for clinical outcome. The first one, Hübner and col.21 shows a prospective pilot study about 70 patients undergoing frequent abdominal procedures of different magnitude. They measured ALB, CRP and CPT once daily starting the day before surgery until postoperative day (POD) 5. The conclusion of the estudy was that early postoperative ALB drop appeared to reflect the magnitud of surgical trauma and was correlated with adverse clinical outcomes. The group continues the same line of work and publishes another prospective cohort study with 138 patients undergoing major abdominal surgery. They collect blood samples before and on POD 0,1,2 and 3. They compare ALB decrease and CPR and CPT. The postoperative outcomes of the study were complications and length of hospital stay. They found a decrease of ALB of 10% yielded a sensitivity of 77.1% and a specificity of 67.2% (AUC : 78.3%) to predict complications. On the other hand, they also found that decrease of ALB of 10% on POD1 showed a threefold increased risk of overall postoperative complications.21 Antoher group, Ge et al.27 made a retrospective study about 626 patients undergoing major colorectal surgery with the main outcome were to identify risk factors for postoperative complications and to identify the factors associated with the ALB decrease. This study revealed the patients with a greater relative decrease in serum ALB in POD 2 were at higher risk of postoperative complications, prolonged postoperative hospital stays, an more Surgical Site infeccions after colorectal surgery. A cutoff value of 15% reduction in serum ALB on POD 2 distinguished patients at low risk and high risk for postoperative complications in an earlier stage and was more accurate the CRP level on POD 3 and 4.
These are the preliminary data that lead us to start our study in order to demonstrate the utility of the postoperative decrease of serum albumin as an early detector of anastomotic leak and infectious complications in patients undergoing major colorectal surgery This study aimed to test the hypotheses that early postoperative albumin drop can predict anastomotic leaks and also can predict postoperative infectious complications earlier than other biological markers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALbumin level | – | Diagnostic Test: Albumine detectionDetection of serum albumin levels in postoperatory of colorectal surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated on scheludec colorectal surgery with primary anastomosis
Key inclusion criteria (5 listed)
- Patients older than 18 years
- Patients undergoing major colorectal surgery (expected to last 2 hours or more)
- Performing primary anastomosis
- Scheluded surgery
- Patients who give their written informed consent
Key exclusion criteria (2 listed)
- Patients not meeting inclusion criteria at any time during the study (surgeries lasting less than 2 hours or anastomosis not performed. urgent surgery, not give written informed consent) will be excluded.
- No other inclusion or exclusion criteria have been considered, however, the investigator should consider any circumstance where the benefit-risk for the patient is not adequate.
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 |
|---|---|---|
| Albumine detectionControl of serum albumine levels in postoperatori of colorectal surgery | Diagnostic test | ALbumin level |
Primary outcome
Determination of serum albumine levels
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Albumin; Double, run by Corporacion Parc Tauli.
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 2 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 Mora Dr. Laura (34639101033, mora.lopez.laura@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of serum albumine levels (time frame: One year). 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 Aug 2018.