Surgical ComplicationslactateNCT01161849
Peritoneal/ Serum Lactate Ratio in Relaparotomy
An observational study of Surgical Complications and Relaparotomy, run by Ospedale S. Giovanni Bosco at 2 sites in Italy.
Trial summary
Laparotomy performed for both emergency of elective surgery may by complicated by intrabdominal collection, anastomotic leakage, infarction and others. This conditions are able to induce peritoneal inflammation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Surgical Complications, Relaparotomy
- How many people
- 60 participants
- Where
- 2 sitesItaly
- Study dates
- Aug 2010to Dec 2010
- 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 admitted to our surgery department for the post operative period after major abdominal surgery (neoplastic and non neoplastic) or urgent laparotomy for traumatic or non traumatic acute abdomen.
Who may be able to join
- Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas)
- Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen
- Patients with signs of sepsis in the post operative period
- Patients with signs of systemic hypoperfusion in the post operative
Who cannot join
- Liver surgery
- Drainage of bile, blood and dejection from abdominal drainage
- Sepsis/ systemic hypoperfusion due to extraabdominal infection site
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Chirurgia Generale e d'Urgenza; Ospedale SG Bosco: aslTO2
Torino, Torino, 10153
Medicina D'Urgenza; Ospedale SG Bosco; ASLTO2
Torino, Torino, 10153
About this study
Official title: Peritoneal/Serum Lactate Ratio in Relaparotomy
Laparotomy performed for both emergency of elective surgery may by complicated by intrabdominal collection, anastomotic leakage, infarction and others. This conditions are able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of lactate that the investigators can measure by collecting fluid from peritoneal drainage.
Drainage were left in abdomen for monitoring intrabdominal condition until the passage of stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post operative period.
Read more
Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and systemic hypoperfusion and it is easy to measure with a blood gas analysis.
The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could be an earlier, sensible, non-invasive, and economical marker of post surgical complications. The decision whether and when to perform a relaparotomy in secondary peritonitis is largely subjective and based on professional experience. Actually no existing scoring system aids in this decision.
The aim of this study is to demonstrate that this ratio could be and useful tool for the surgeon in this decisional process.
Read the detailed description
Post operative intraabdominal sepsis due to surgical complications is associated with an important mortality and morbidity. Early diagnosis is crucial to improve outcome. Relaparotomy could be necessary to eradicate the intraabdominal focus of sepsis or hypoperfusion. The relaparotomy must be performed early after the diagnosis of surgical complications before the onset of multi organ failure.
This prospective observational study includes the post operative period of consecutive patients requiring both major elective surgery and urgent laparotomy.
Demographic data, presence and nature of underlying disease and surgical diagnosis will be recorded on admission and study inclusion.
Daily after study inclusion, the investigators measure: venous blood gases, blood lactate and lactate presents in the fluid collected from the abdomen. Possum and SAPSII scores will be calculated daily or when a patient develops a rapid clinical deterioration.
The investigators follow patients with complicated or uncomplicated post operative period.
Post operative complications are defined as: mesenteric ischemia, need for reintervention, anastomotic leakage or fistula, secondary peritonitis and death.
The primary end point is to demonstrate the correlation between surgical complications and serum/abdominal lactate ratio.
The second end point is to verify the correlation between need to relaparotomy and Possum an SAPSII scores.
- Conditions
- Surgical Complications, Relaparotomy
- Keywords
- lactate, urgent surgery, major surgery, surgical complications, possum, sapsII, relaparotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Surgical ComplicationsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale S. Giovanni Bosco
- Sponsor type
- University, hospital or other
- Investigators
- roberto bini, md, Principal investigator, Chirurgia d'urgenzaGiovanni Ferrari, MD, Principal investigator, Medicina d'urgenzaRenzo Leli, MD, Study chair, Chirurgia d'urgenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161849
- Sponsor's protocol ID
- Lali2010
- Acronym
- lactate
- Status last verified
- Jul 2010
- First submitted
- 21 Jun 2010
- Last updated
- 4 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
DeLaurier GA, Ivey RK, Johnson RH. Peritoneal fluid lactic acid and diagnostic dilemmas in acute abdominal disease. Am J Surg. 1994 Mar;167(3):302-5. doi: 10.1016/0002-9610(94)90204-6.
PubMed 8160901Paugam-Burtz C, Dupont H, Marmuse JP, Chosidow D, Malek L, Desmonts JM, Mantz J. Daily organ-system failure for diagnosis of persistent intra-abdominal sepsis after postoperative peritonitis. Intensive Care Med. 2002 May;28(5):594-8. doi: 10.1007/s00134-002-1250-5. Epub 2002 Mar 15.
PubMed 12029408Reynaert MS, Bshouty ZH, Bertrand C, Cambier-Kremer C, Calteux N, Carlier M, Col J, Tremouroux J. Early diagnosis of peritoneal infection by simultaneous measurement of lactate concentration in peritoneal fluid and blood. Intensive Care Med. 1984;10(6):301-4. doi: 10.1007/BF00254320.
PubMed 6512075van Ruler O, Lamme B, Gouma DJ, Reitsma JB, Boermeester MA. Variables associated with positive findings at relaparotomy in patients with secondary peritonitis. Crit Care Med. 2007 Feb;35(2):468-76. doi: 10.1097/01.CCM.0000253399.03545.2D.
PubMed 17205025van Ruler O, Mahler CW, Boer KR, Reuland EA, Gooszen HG, Opmeer BC, de Graaf PW, Lamme B, Gerhards MF, Steller EP, van Till JW, de Borgie CJ, Gouma DJ, Reitsma JB, Boermeester MA; Dutch Peritonitis Study Group. Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial. JAMA. 2007 Aug 22;298(8):865-72. doi: 10.1001/jama.298.8.865.
PubMed 17712070Novotny AR, Emmanuel K, Hueser N, Knebel C, Kriner M, Ulm K, Bartels H, Siewert JR, Holzmann B. Procalcitonin ratio indicates successful surgical treatment of abdominal sepsis. Surgery. 2009 Jan;145(1):20-6. doi: 10.1016/j.surg.2008.08.009. Epub 2008 Sep 26.
PubMed 19081471Lamme B, Mahler CW, van Ruler O, Gouma DJ, Reitsma JB, Boermeester MA. Clinical predictors of ongoing infection in secondary peritonitis: systematic review. World J Surg. 2006 Dec;30(12):2170-81. doi: 10.1007/s00268-005-0333-1.
PubMed 17102920Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.
PubMed 17122625Komen N, de Bruin RW, Kleinrensink GJ, Jeekel J, Lange JF. Anastomotic leakage, the search for a reliable biomarker. A review of the literature. Colorectal Dis. 2008 Feb;10(2):109-15; discussion 115-7. doi: 10.1111/j.1463-1318.2007.01430.x.
PubMed 18199290Bini R, Ferrari G, Apra F, Viora T, Leli R, Cotogni P. Peritoneal lactate as a potential biomarker for predicting the need for reintervention after abdominal surgery. J Trauma Acute Care Surg. 2014 Aug;77(2):376-80. doi: 10.1097/TA.0000000000000302.
PubMed 25058267
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peritoneal/Serum Lactate Ratio in Relaparotomy
- ClinicalTrials.gov ID
- NCT01161849
- Acronym / sponsor ID
- lactate / Lali2010
- Conditions
- Surgical Complications, Relaparotomy
- Keywords
- lactate, urgent surgery, major surgery, surgical complications, possum, sapsII, relaparotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ospedale S. Giovanni BoscoUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Jul 2010 (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.
Laparotomy performed for both emergency of elective surgery may by complicated by intrabdominal collection, anastomotic leakage, infarction and others. This conditions are able to induce peritoneal inflammation. Inflamed peritoneum are able to produce excess of lactate that the investigators can measure by collecting fluid from peritoneal drainage.
Drainage were left in abdomen for monitoring intrabdominal condition until the passage of stool or flatus. Minimum drainage of serum is present daily also in uncomplicated post operative period.
Serum lactate relates with increased systemic anaerobic metabolism such as SIRS, sepsis and systemic hypoperfusion and it is easy to measure with a blood gas analysis.
The investigators hypothesized that the increases of peritoneal/ serum lactate ratio could be an earlier, sensible, non-invasive, and economical marker of post surgical complications. The decision whether and when to perform a relaparotomy in secondary peritonitis is largely subjective and based on professional experience. Actually no existing scoring system aids in this decision.
The aim of this study is to demonstrate that this ratio could be and useful tool for the surgeon in this decisional process.
Detailed description
Post operative intraabdominal sepsis due to surgical complications is associated with an important mortality and morbidity. Early diagnosis is crucial to improve outcome. Relaparotomy could be necessary to eradicate the intraabdominal focus of sepsis or hypoperfusion. The relaparotomy must be performed early after the diagnosis of surgical complications before the onset of multi organ failure.
This prospective observational study includes the post operative period of consecutive patients requiring both major elective surgery and urgent laparotomy.
Demographic data, presence and nature of underlying disease and surgical diagnosis will be recorded on admission and study inclusion.
Daily after study inclusion, the investigators measure: venous blood gases, blood lactate and lactate presents in the fluid collected from the abdomen. Possum and SAPSII scores will be calculated daily or when a patient develops a rapid clinical deterioration.
The investigators follow patients with complicated or uncomplicated post operative period.
Post operative complications are defined as: mesenteric ischemia, need for reintervention, anastomotic leakage or fistula, secondary peritonitis and death.
The primary end point is to demonstrate the correlation between surgical complications and serum/abdominal lactate ratio.
The second end point is to verify the correlation between need to relaparotomy and Possum an SAPSII scores.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to our surgery department for the post operative period after major abdominal surgery (neoplastic and non neoplastic) or urgent laparotomy for traumatic or non traumatic acute abdomen.
Key inclusion criteria (4 listed)
- Post operative period of abdominal surgery (elective surgery of:colon-rectum, ileum, stomach and, pancreas)
- Post operative period after Urgent laparotomy for both traumatic and/or non traumatic acute abdomen
- Patients with signs of sepsis in the post operative period
- Patients with signs of systemic hypoperfusion in the post operative
Key exclusion criteria (3 listed)
- Liver surgery
- Drainage of bile, blood and dejection from abdominal drainage
- Sepsis/ systemic hypoperfusion due to extraabdominal infection site
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
Not reported in the source record.
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 4 Jan 2011.
- Background: PubMed 8160901DeLaurier GA, Ivey RK, Johnson RH. Peritoneal fluid lactic acid and diagnostic dilemmas in acute abdominal disease. Am J Surg. 1994 Mar;167(3):302-5. doi: 10.1016/0002-9610(94)90204-6.
- Background: PubMed 12029408Paugam-Burtz C, Dupont H, Marmuse JP, Chosidow D, Malek L, Desmonts JM, Mantz J. Daily organ-system failure for diagnosis of persistent intra-abdominal sepsis after postoperative peritonitis. Intensive Care Med. 2002 May;28(5):594-8. doi: 10.1007/s00134-002-1250-5. Epub 2002 Mar 15.
- Background: PubMed 6512075Reynaert MS, Bshouty ZH, Bertrand C, Cambier-Kremer C, Calteux N, Carlier M, Col J, Tremouroux J. Early diagnosis of peritoneal infection by simultaneous measurement of lactate concentration in peritoneal fluid and blood. Intensive Care Med. 1984;10(6):301-4. doi: 10.1007/BF00254320.
- Background: PubMed 17205025van Ruler O, Lamme B, Gouma DJ, Reitsma JB, Boermeester MA. Variables associated with positive findings at relaparotomy in patients with secondary peritonitis. Crit Care Med. 2007 Feb;35(2):468-76. doi: 10.1097/01.CCM.0000253399.03545.2D.
- Background: PubMed 17712070van Ruler O, Mahler CW, Boer KR, Reuland EA, Gooszen HG, Opmeer BC, de Graaf PW, Lamme B, Gerhards MF, Steller EP, van Till JW, de Borgie CJ, Gouma DJ, Reitsma JB, Boermeester MA; Dutch Peritonitis Study Group. Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial. JAMA. 2007 Aug 22;298(8):865-72. doi: 10.1001/jama.298.8.865.
- Background: PubMed 19081471Novotny AR, Emmanuel K, Hueser N, Knebel C, Kriner M, Ulm K, Bartels H, Siewert JR, Holzmann B. Procalcitonin ratio indicates successful surgical treatment of abdominal sepsis. Surgery. 2009 Jan;145(1):20-6. doi: 10.1016/j.surg.2008.08.009. Epub 2008 Sep 26.
- Background: PubMed 17102920Lamme B, Mahler CW, van Ruler O, Gouma DJ, Reitsma JB, Boermeester MA. Clinical predictors of ongoing infection in secondary peritonitis: systematic review. World J Surg. 2006 Dec;30(12):2170-81. doi: 10.1007/s00268-005-0333-1.
- Results publication: PubMed 17122625Verdant CL, Chierego M, De Moor V, Chamlou R, Creteur J, de Dieu Mutijima J, Loi P, Gelin M, Gullo A, Vincent JL, De Backer D. Prediction of postoperative complications after urgent laparotomy by intraperitoneal microdialysis: A pilot study. Ann Surg. 2006 Dec;244(6):994-1002. doi: 10.1097/01.sla.0000225092.45734.e6.
- Results publication: PubMed 18199290Komen N, de Bruin RW, Kleinrensink GJ, Jeekel J, Lange JF. Anastomotic leakage, the search for a reliable biomarker. A review of the literature. Colorectal Dis. 2008 Feb;10(2):109-15; discussion 115-7. doi: 10.1111/j.1463-1318.2007.01430.x.
- Derived from this study: PubMed 25058267Bini R, Ferrari G, Apra F, Viora T, Leli R, Cotogni P. Peritoneal lactate as a potential biomarker for predicting the need for reintervention after abdominal surgery. J Trauma Acute Care Surg. 2014 Aug;77(2):376-80. doi: 10.1097/TA.0000000000000302.
Related trials for Surgical Complications
Active, not recruitingPhase 3
Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v7
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
Recruiting
Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Surgery
RecruitingPhase 1
A Study of Amicidin-β Topical Solution for Patients With a Contaminated or Infected Surgical or Traumatic Wound or Cutaneous Abscess
Surgical Wound Infection, Traumatic Wound Infection
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.
roberto bini, md principal investigator
Chirurgia d'urgenza
Giovanni Ferrari, MD principal investigator
Medicina d'urgenza
Renzo Leli, MD study chair
Chirurgia d'urgenza
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Complications and Relaparotomy, run by Ospedale S. Giovanni Bosco at 2 sites in Italy.
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 4 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 4 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01161849, which also lists 10 linked publications.
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 4 Jan 2011.