Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
60 participants
OBSERVATIONAL
2010-08-31
2010-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lactate Metabolism in the Hypoperfused Critically Ill
NCT05582824
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
NCT03553394
Refeeding Like Syndrome in Acute Disease
NCT04966780
Feasibility of Lactate Level Evaluation in Prehospital Care in Trauma
NCT03115970
Fluid Management Surgical Patients in Intensive Care Unit.
NCT03455296
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* Drainage of bile, blood and dejection from abdominal drainage
* Sepsis/ systemic hypoperfusion due to extraabdominal infection site
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ospedale S. Giovanni Bosco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Chirurgia d'urgenza
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
roberto bini, md
Role: PRINCIPAL_INVESTIGATOR
Chirurgia d'urgenza
Giovanni Ferrari, MD
Role: PRINCIPAL_INVESTIGATOR
Medicina d'urgenza
Renzo Leli, MD
Role: STUDY_CHAIR
Chirurgia d'urgenza
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chirurgia Generale e d'Urgenza; Ospedale SG Bosco: aslTO2
Torino, Torino, Italy
Medicina D'Urgenza; Ospedale SG Bosco; ASLTO2
Torino, Torino, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Paugam-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.
Reynaert 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.
van 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.
van 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.
Novotny 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.
Lamme 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.
Verdant 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.
Komen 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.
Bini 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Lali2010
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.