Peritoneal/ Serum Lactate Ratio in Relaparotomy

NCT01161849 | Completed DMC

• 1 other identifier: Lali2010
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Surgical Complications; Relaparotomy

Keywords

lactate; urgent surgery; major surgery; surgical complications; possum; sapsII; relaparotomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Liver surgery
• Drainage of bile, blood and dejection from abdominal drainage
• Sepsis/ systemic hypoperfusion due to extraabdominal infection site

Sponsors & Collaborators

• Ospedale S. Giovanni Bosco: lead

Study Sites (2)

Chirurgia Generale e d'Urgenza; Ospedale SG Bosco: aslTO2

Torino, Torino, 10153, Italy

Location

Medicina D'Urgenza; Ospedale SG Bosco; ASLTO2

Torino, Torino, 10153, Italy

Location

Related Publications (10)

• 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.

  PMID: 8160901 BACKGROUND

• 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.

  PMID: 12029408 BACKGROUND

• 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.

  PMID: 6512075 BACKGROUND

• 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.

  PMID: 17205025 BACKGROUND

• 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.

  PMID: 17712070 BACKGROUND

• 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.

  PMID: 19081471 BACKGROUND

• 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.

  PMID: 17102920 BACKGROUND

• 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.

  PMID: 17122625 RESULT

• 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.

  PMID: 18199290 RESULT

• 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.

  PMID: 25058267 DERIVED

Study Officials

• roberto bini, md

  Chirurgia d'urgenza

  PRINCIPAL INVESTIGATOR

• Giovanni Ferrari, MD

  Medicina d'urgenza

  PRINCIPAL INVESTIGATOR

• Renzo Leli, MD

  Chirurgia d'urgenza

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2010
• First Posted: July 14, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2010-07

Locations

IT (2)