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

Phase 4

Withdrawn

• Conditions: Renal Colic
• Interventions: Drug: 0.9% Sodium-chloride; Drug: Placebos; Drug: Optalgin, Voltaren, Morphine

• Registration Number: NCT03529097
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

Detailed 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?

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-05-17
• Study First Posted: 2018-05-18
• Study Start: 2018-06-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluids	0.9% Sodium-chloride	Intervention: 2 liters of 0.9% NaCl IV during the ER stay with pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not
Fluids	Optalgin, Voltaren, Morphine	Intervention: 2 liters of 0.9% NaCl IV during the ER stay with pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not
Placebo	Placebos	No interventions, Only pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not
Placebo	Optalgin, Voltaren, Morphine	No interventions, Only pain killers. For placebo purposes this arm participants will get an infusion with black cover so they could not tell if it drips or not

Primary Outcome Measures

Name	Time	Method
Pain	6 hours	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
Stone ejection without intervention	1 month	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)
The need for urological intervention	0 to 1 month	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)

Secondary Outcome Measures

Name	Time	Method
Pain	1 month	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