Evaluation of the Roll of IV Fluids in the Treatment of Renal Colic

Renal Colic Clinical Trial

Official title:

Randomized Controlled Trial to Evaluate the Efficiency of IV Fluids in the Treatment of Renal Colic

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03529097
• Other study ID #: SHEBA-18-4262-NK-CTIL
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomised controlled trial to evaluate the role of IV fluids in renal colic.

Description:

A RCT (Randomized Controlled Trial)to evaluate the role of 0.9% NACL (sodium chloride) IV fluids during an acute renal colic. The 2 arms will include -

1. 2 liters of 0.9% NACL IV fluids with pain killers

2. only pain killers The object is to find out if the IV fluids has any advantage in the care of renal colic. Does it helps to relive the pain? Does the stone eject earlier? Will there be fewer interventions?

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• above 18 years

• clinical renal colic

• a radiological proof (CT,US) to urolithiasis

Exclusion Criteria:

• below 18 years

• has a contraindication for IV fluids (such as CHF (Congestive Heart Failure)etc.)

Related Conditions & MeSH terms

• Colic
• Renal Colic

Intervention

Drug:
• 0.9% Sodium-chloride
2 liters of 0.9% NaCl IV fluids
• Placebos
2 liters of 0.9% NaCl bag covered with black bag so the participant could not tell the fluids are not dripping to his vain
• Optalgin, Voltaren, Morphine
Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone ejection without intervention	Has the stone ejected without intervention? 1 month after the first visit in the ER (Emergency Room) we will preform an US or CT exam to verified that the stone ejected. If the stone that was seen by the US or CT in the ER is not present after 1 month we will assume it was spontaneously ejected. we would like to find out if there is any differences between the 2 groups in matter of spontaneously stone ejection. (Yes or No)	1 month
Primary	The need for urological intervention	The need for urological intervention. 1 month after the visit in the ER we will check if the patient have gone through urological intervention such as urolithiasis. We would like to find out if there is any difference between the two groups in matter of urological intervention between 1 month after the visit in the ER. (Yes or No)	0 to 1 month
Primary	Pain	Measure the VAS (Visual Analogue pain Score). Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 6 hours of treatment in the ER	6 hours
Secondary	Pain	Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 hour of treatment in the ER	1 Hour
Secondary	Pain	Measure the VAS Between 1-10 1 is no pain and 10 in the strongest pain. a scale between 1-10 is shown to the patients and they are asked how they feel after 1 month from the first visit in the ER	1 month