Clinical Research Details

Descriptive Information
Beyond the pilot: a clinical decision rule for patients presenting with acute renal colic

Eveline Hitti

Completed- Has Results


  • Afif Mufarrij
Rana Bachir
Conditions and Keywords
Acute renal colic
Flank pain,Unenhanced Helical Computed Tomography (UHCT) ,prospective study,decision rule
Study Design
Other: Describe in Detailed Description
To develop decision rules
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
N/A: Not Applicable
Eligibility and IRB
Min: 19

Study Objectives

The main objectives behind this study are:

(i)        To develop a structured data collection tool for evaluation of patients with acute flank pain.

(ii)        To conduct a two years prospective study on ED patients presenting with acute flank pain suggestive of renal colic.

(iii)        To assess the inter-observer reliability of the clinical findings.

(iv)      To develop an accurate, reliable and sensitive clinical decision rule that guides the use of CT for patients with acute flank pain.

Outcome measures

The outcomes that will be measured in this study, and more specifically during the follow-up assessment survey, are divided into primary and secondary. The primary outcome is a composite parameter based on the development of a serious result within two weeks of presentation of any of the following: death, acute renal injury, sepsis, need for acute urologic intervention and need for acute non-urologic surgical intervention. Death will be confirmed through the findings in the medical record. Acute renal injury will be defined according to the RIFLE criteria as a twofold increase in the serum creatinine, or GFR decrease by 50 percent, or urine output <0.5 mL/kg per hour for 12 hours (Bellomo et al, 2004). Sepsis will be defined in accordance with the 2001 International Sepsis Definitions Conference, as the presence of the systemic inflammatory response syndrome with an existing infection (Levy et al, 2003). The need for acute urologic or non-urologic intervention will be considered if the intervention was related to the initial complaint and failure to intervene would cause the patient a serious outcome. Admission for intravenous fluids or pain/nausea control will not be considered as a serious outcome.

The secondary outcome will include hospitalization or representation to the ED for intravenous fluids or pain/nausea control for a condition related to the initial presentation. 

The targeted population for the prospective study will include all patients above the age of 18 presenting to the AUBMC ED with complaints suggestive of urolithiasis or nephrolithiasis during a period of two years from November 1, 2011 until October 31, 2013. Eligibility for the study will be determined by the attending physician after assessing the patient on arrival to the ED. If the following characteristics are both met, the patient will be included in the study.

  1. Patient is 18 years or older.
  2. Patient presents flank pain, back pain, groin pain or abdominal pain suspicious for acute renal colic.

This is a prospective study that involves the enrollment of patients presenting to the ED over a period of two years and meeting specific criteria, and follow up with them after a period of two weeks.

  1. Patient is 18 years or older.
  2. Patient presents flank pain, back pain, groin pain or abdominal pain suspicious for acute renal colic.

  1. Patient is younger than 18 years of age.
  2. Patient has comorbidity of solitary kidney
  3. Patient has comorbidity of anticoagulation
  4. Patient has comorbidity of cancer
  5. Patient is taking the medication “sintrom” 
  6. Patient has left against medical advice or before completing the recommended evaluation
  7. Patient is a pregnant woman
  8. Patient presents with history of severe trauma during the past 3 months
  9. Patient has colon, ovarian or urologic malignancy
  10. Patient has metastatic lumps in the abdomen
  11. Renal colic is clearly not suspected