lactate: Peritoneal/ Serum Lactate Ratio in Relaparotomy

Sponsor

Ospedale S. Giovanni Bosco (Other)

Overall Status

Completed

CT.gov ID

NCT01161849

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Complications Relaparotomy

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

Study Type:

Observational

Anticipated Enrollment :

60 participants

Time Perspective:

Prospective

Official Title:

Peritoneal/Serum Lactate Ratio in Relaparotomy

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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